Z-1507-2025Class I
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355...
Bard Access Systems, Inc. / initiated 2025-03-11 / Open, Classified / root cause: manufacturing process
Bard Access Systems, Inc. began a recall of BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617... on . FDA classified it as Class I and gives the reason as "Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1507-2025
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Bard Access Systems, Inc.
- Product
- BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784
- Product code
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Reason for recall
- Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- On 3/11/2025, recall notices were distributed to customers and distributors who were asked to do the following: Actions if catheter damage is suspected: 1. Stop any infusion if catheter damage is suspected. 2. Follow your institution's guidelines for catheters with suspected damage. 3. If catheter fracture is confirmed, catheter should be removed and an alternative route for access should be obtained. 4. Report any catheter replacements due to leakage to firm's Complaint Center. Please Take the Following Actions: 1. Destroy all unused product following your institution's process for destruction. 2. If affected device was previously used on a patient without incident, no further action is necessary. 3. Recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. 4. Complete and return Customer Response Form via email to Email: [email protected] Distributors asked to identify all customers within distribution network that purchased any affected product. Provide a copy of the attached customer letter to all customers to advise them of this recall Actions Taken by Firm: 2. Firm is notifying users that adhesive-backed securement systems are recommended. 3. Firm is notifying users that if they do use compression-style securement systems, they must be sized appropriately to accommodate the taper region. 4. Firm has been updating the product IFU with cautions related to the use of compression-style securement systems around the taper region of the PICC. 5. Firm is notifying customers to insert the catheter as close as possible to the zero mark per the IFU. For further assistance, contact: North American Regional Complaint Center: 1-844-823-5433 Mon-Fri 8:00am and 5:00pm CT or [email protected]. On 5/15/2025 additional recall notices were distributed to customers informing them of additional affected devices.
- Quantity in commerce
- 718,461
- Distribution
- Worldwide - US Nationwide distribution including in the states of WI, NC, TX, NY, CA, MN, MT, RI, MA, OH, CT, SC, IL, CO, VA, NJ, GA, UT, FL, PA, IN, MD, KY, AZ, MI, WA, HI, MO, VT, AL, NM, TN, DE, LA, IA, NH, ID, DC, WV, KS, NE, SD, ND, WY, AK, OK, OR, AR and the countries of Andorra, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, French Polynesia, French Guayana, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic of Korea, Reunion, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Viet Nam.
- Product codes and lots
- REF/UDI-DI/Lot(Expiration): 3174155/00801741027611/REGQ0844(6/30/2025), REGZ1439(11/30/2025), REHP0860(11/30/2025), REHQ3097(6/30/2026), REHR0022(6/30/2026), REHT1151(7/31/2026), REHU1525(11/30/2026), REHU2455(6/30/2026), REHU2614(11/30/2026), REHV2765 (7/31/2026), REJN3472(2/28/2027), REJP4216(5/31/2027), REJQ2272(7/31/2027), REJR1411(8/31/2027), REJR2565(4/30/2027), REJR2614(8/31/2027), REJT0755(9/30/2027); CK000540/00801741105142/REGZ1425(10/31/2025), REHP0808(11/30/2025), REHU1513(1/31/2026), REHV2221(1/31/2026), REHY2842(10/31/2026), REJN4145 (12/31/2026), REJR1322(3/31/2027), REJS2110(4/30/2027), REJS3773(2/28/2027); 3174118/00801741027598/REGZ2512(11/30/2025), REHP1760(1/31/2026), REHP2603(1/31/2026), REJN1059(12/31/2026); CK000483/00801741099397/REHN3187(10/31/2025), REHQ1804(6/30/2026), REJN1065(5/31/2027), REJP2018(6/30/2027), REJR1321(8/31/2027); 3174335/00801741027628/REHN3908(10/31/2025), REHP0800(10/31/2025), REHQ3070(11/30/2025), REHT1129(5/31/2026), REHU1519(6/30/2026), REHV1391(7/31/2026), REHV3050(7/31/2026), REHZ1011(11/30/2026), REJN4109(12/31/2026), REJQ0405(2/28/2027), REJR2090(3/31/2027), REJT0833(5/31/2027); 3174355/00801741027635/REHQ1781(11/30/2025), REHS1925(4/30/2026), REHT1120(5/31/2026), REHU0975(6/30/2026), REHU2488(6/30/2026), REHV1400(7/31/2026), REHV3020(7/31/2026), REHW1329(8/31/2026), REHY1684(10/31/2026), REHZ1903(11/30/2026), REJN3007(12/31/2026), REJP0855(1/31/2027), REJP2021(1/31/2027), REJQ2284(2/28/2027), REJR2157(3/31/2027), REJS2171(4/30/2027), REJS4490(4/30/2027); CK000196/00801741028847/REHQ3064(6/30/2026), REHT2954(1/31/2026), REHX2926(12/31/2026), REHZ1873(3/31/2027), REJQ2279(8/31/2027); 9174118/00801741035562/REHQ3091(6/30/2026), REHR0017(6/30/2026), REHT1132(6/30/2026), REHU2496(6/30/2026), REHY2811(2/28/2026), REHZ1882(3/31/2027); CK000955/00801741200922/REHQ4029(11/30/2025), REHV2232(2/28/2026), REHX2916(12/31/2025), REHY3954(7/31/2026), REJN2995(9/30/2025); 3174135/00801741027604/REHR0003(11/30/2025), REHS4184(7/31/2026), REHU2356(11/30/2026), REHU2612(6/30/2026), REJS2089(9/30/2027); CK000617/00801741122286/REHS1001(9/30/2025), REJQ2280(2/28/2027); CK000839/00801741154393/REHS4241(4/30/2026), REHV3026(7/31/2026), REHX2908(9/30/2026), REHY2826(10/31/2026), REJN3000(12/31/2026), REJS3479(4/30/2027); 3194355/00801741027789/REHT2157(5/31/2025), REHT2967(5/31/2025), REHU3317(6/30/2025), REHV3031(7/31/2025), REHY3957(10/31/2025), REHZ1878(11/30/2025), REJN3008(12/31/2025), REJR1276(12/31/2025), REJR2062(3/31/2026), REJS2065(12/31/2025); 6174118/00801741139017/REHT2984(1/31/2026); 3194135/00801741027758/REHU1029(5/31/2025), REHY1636(10/31/2025), REHY2820(10/31/2025), REJN2980(12/31/2025); 3194335/00801741027772/REHU1430(6/30/2025), REHU2339(6/30/2025), REHW1354(8/31/2025), REHY2700(10/31/2025), REHZ1026(10/31/2025), REJN1463(12/31/2025), REJN3016(12/31/2025), REJR2013(3/31/2026), REJS3853(12/31/2025); 2174108/00801741138966/REHU3327(9/30/2025); 9194118/00801741028618/REHV0263(6/30/2025), REJQ0411(1/31/2026); 3194118/00801741027741REHY1654(10/31/2025), REJP0843(5/31/2025), REJS0206(3/31/2026); 1174118/00801741034466/REHY2815(5/31/2025), REJN1443(8/31/2025), REJQ0415(5/31/2025), REJQ2243(8/31/2025), REJS4488(10/31/2025); CK000285C/00801741161117/REHZ1477(5/31/2025), REJN2365(5/31/2025), REJQ2812(8/31/2025), REJR2208(9/30/2025), REJS1287(9/30/2025), REJS4740(10/31/2025); CK000335A/00801741101281/REHZ1620(5/31/2025), REJN2425(6/30/2025), REJQ0819(8/31/2025), REJQ1491(8/31/2025); CK000796/00801741144783/REHZ1625(5/31/2025), REJQ1521(8/31/2025), REJR1458(9/30/2025), REJS0258(9/30/2025), REJS3583(10/31/2025), REJT0877(11/30/2025), REJX0310(2/28/2026); 1194108D/00801741034510/REHZ1633(5/31/2025), REJN3882(5/31/2025), REJN3972(6/30/2025), REJP4057(7/31/2025), REJP4060(7/31/2025), REJP4066(7/31/2025), REJP4068(7/31/2025), REJR2209(9/30/2025), REJR2227(9/30/2025), REJS1269(9/30/2025), REJS2211(9/30/2025), REJS3526(10/31/2025), REJU1142(10/31/2025), REJV3948(1/31/2026); CK000757/00801741141133/REHZ1652(5/31/2025), REJQ0793(6/30/2025), REJR1443(8/31/2025), REJS1253(7/31/2025), REJS3543(8/31/2025), REJV0288(10/31/2025); CK001042/00801741224324/REHZ1657(5/31/2025), REJN2389(6/30/2025), REJR1448(9/30/2025), REJT0890(11/30/2025); 9174108/00801741035548/REJN0035(6/30/2025), REJQ0431(8/31/2025), REJR0582(9/30/2025); 1174108D1/00801741154737/REJN0722(5/31/2025), REJP1731(7/31/2025), REJR0469(8/31/2025), REJR2556(9/30/2025), REJS2083(10/31/2025); CK000631B/00801741143748/REJN0748(5/31/2025), REJP2723(7/31/2025), REJP2747(7/31/2025), REJS1310(9/30/2025), REJS4709(10/31/2025); 3194155/00801741027765/REJN0964(6/30/2025), REJN1080(6/30/2025), REJN4126(6/30/2025), REJQ0418(8/31/2025), REJS3757(10/31/2025), REJT1225(11/30/2025); 3174108/00801741027574/REJN1098(6/30/2025), REJR2206(9/30/2025), REJS2212(10/31/2025); CK000567/00801741108167/REJN1450(5/31/2025), REJQ0400(8/31/2025); 1194108D4/00801741155093/REJN2245(5/31/2025), REJP1828(7/31/2025), REJQ1321(6/30/2025), REJR0440(6/30/2025), REJR2590(7/31/2025), REJS2165(7/31/2025), REJS4634(7/31/2025); 1174108D2/00801741154836/REJN2302(5/31/2025), REJP1701(5/31/2025), REJQ1440(8/31/2025), REJR1289(9/30/2025), REJR2589(9/30/2025), REJS2453(10/31/2025), REJS4511(9/30/2025), REJU1046(11/30/2025); CK000677/00801741131790/REJN2329(5/31/2025), REJR1433(9/30/2025), REJS3919(10/31/2025); CK000864/00801741163302/REJN2340(5/31/2025), REJR1423(7/31/2025), REJR2685(7/31/2025), REJS2226(6/30/2025); CK000937A/00801741224003/REJN2347(5/31/2025), REJQ0824(6/30/2025), REJR2631(7/31/2025), REJS3571(8/31/2025); CK000930/00801741188091/REJN2351(5/31/2025), REJR2649(9/30/2025); CK001027/00801741223921/REJN2359(5/31/2025), REJR2690(9/30/2025), REJT1434(9/30/2025); 1174108D/00801741034459/REJN2362(5/31/2025), REJN2363(5/31/2025), REJP4065(7/31/2025), REJQ0816(8/31/2025), REJR0595(9/30/2025), REJR0600(9/30/2025), REJR2677(9/30/2025), REJS1284(9/30/2025), REJS2210(10/31/2025), REJS3915(10/31/2025), REJS4729(10/31/2025); CK000867/00801741163272/REJN2377(5/31/2025); CK000900/00801741184956/REJN2381(5/31/2025), REJR0589(6/30/2025), REJR1461(6/30/2025), REJS1259(6/30/2025), REJS2603(6/30/2025); CK000315A/00801741182723/REJN2391(6/30/2025), REJN3978(5/31/2025), REJQ2835(8/31/2025), REJR2697(9/30/2025), REJT1407(11/30/2025); CK000589A/00801741137624/REJN2395(6/30/2025), REJR2198(7/31/2025); CK000854B/00801741225802/REJN2400(6/30/2025), REJN3856(6/30/2025), REJQ2816(8/31/2025), REJS1317(9/30/2025), REJT0876(11/30/2025); CK000897/00801741184925/REJN2404(6/30/2025), REJN3860(6/30/2025), REJQ2807(6/30/2025), REJR2686(7/31/2025), REJS0277(7/31/2025), REJS1295(6/30/2025), REJT0874(7/31/2025); CK000953A/00801741223303/REJN2409(6/30/2025), REJS2228(8/31/2025), REJV1726(1/31/2026); CK000586B/00801741212789/REJN2420(6/30/2025), REJR1455(6/30/2025), REJR2211(7/31/2025); CK000549/00801741107313/REJN2427(6/30/2025), REJU2672(12/31/2025); CK000844/00801741154690/REJN3737(5/31/2025), REJS0060(9/30/2025); 1194108D1/00801741154782/REJN3778(5/31/2025), REJQ1238(8/31/2025), REJR2004(8/31/2025), REJS1173(7/31/2025); 1174108D4/00801741155048/REJN3820(5/31/2025), REJP1880(7/31/2025), REJR0536(6/30/2025), REJR1407(8/31/2025), REJR2563(6/30/2025), REJS2541(8/31/2025), REJS3729(7/31/2025); 1194108D3/00801741154997/REJN3821(5/31/2025), REJP3949(5/31/2025), REJR0537(9/30/2025), REJR2557(7/31/2025), REJS2084(10/31/2025), REJS4512(10/31/2025), REJU0239(11/30/2025); CK000934/00801741188381/REJN3864(6/30/2025), REJQ1483(8/31/2025), REJS4722(10/31/2025); CK000986/00801741216008/REJN3867(6/30/2025), REJN3923(5/31/2025), REJQ0825(7/31/2025), REJQ1499(7/31/2025), REJR2670(9/30/2025), REJS1324(10/31/2025), REJS4724(10/31/2025); CK000411/00801741096303/REJN3872(5/31/2025); CK001018/00801741222993/REJN3880(6/30/2025), REJQ1526(8/31/2025), REJT1397(9/30/2025); 1174108/00801741034442/REJN3881(5/31/2025), REJQ0432(8/31/2025), REJR2638(9/30/2025); CK000060/00801741028731/REJN3891(6/30/2025), REJQ0799(8/31/2025), REJQ1517(8/31/2025), REJR1432(9/30/2025), REJS1329(10/31/2025), REJS3916(10/31/2025); CK000513A/00801741110030/REJN3898(5/31/2025), REJS3539(8/31/2025); CK001021/00801741222863/REJN3927(6/30/2025) CK001030/00801741223976/REJN3970(6/30/2025), REJS0262(8/31/2025); CK000501A/00801741140815/REJN3980(6/30/2025), REJR2220(9/30/2025), REJT1408(11/30/2025), REJU2651(12/31/2025); CK000619A/00801741132001/REJN3985(6/30/2025); CK000903/00801741183089/REJN3999(6/30/2025), REJS0283(9/30/2025), REJT0909(11/30/2025); 3194108/00801741027710/REJN4166(6/30/2025), REJS3535(10/31/2025); 1194108D2/00801741154881/REJP0630(7/31/2025), REJR0470(8/31/2025), REJR0502(9/30/2025), REJS2556(10/31/2025); 9194108D/00801741035609/REJP1767(7/31/2025), REJR2695(9/30/2025); CK000959/00801741200960/REJP1942(7/31/2025), REJQ1524(8/31/2025), REJS0284(9/30/2025); CK000613/00801741121395/REJP1943(7/31/2025), REJQ1493(8/31/2025), REJR1670(9/30/2025), REJS0293(9/30/2025), REJS2216(10/31/2025), REJS4779(10/31/2025), REJV1721(1/31/2026); CK000991/00801741213298/REJP1950(5/31/2025), REJQ1512(8/31/2025), REJT1415(9/30/2025); CK000983/00801741225734/REJP2027(7/31/2025), REJP4183(7/31/2025), REJS1105(10/31/2025), REJS3409(10/31/2025); CK000881/00801741188787/REJP2717(7/31/2025), REJR1424(8/31/2025); CK000721/00801741137655/REJP2725(7/31/2025), REJR2213(9/30/2025), REJS1291(9/30/2025), REJT1365(11/30/2025); CK000642/00801741127908/REJP2727(7/31/2025), REJT0895(10/31/2025); CK000289C/00801741161148/REJP2728(7/31/2025), REJQ0813(8/31/2025), REJR2219(9/30/2025), REJS2203(9/30/2025), REJT1406(11/30/2025), REJV0222(9/30/2025), REJV1719(9/30/2025), REJX3527(1/31/2026); CK000894A/00801741188732/REJP2737(5/31/2025), REJS2218(10/31/2025); CK000914/00801741202599/REJP2741(7/31/2025), REJR1425(8/31/2025), REJS1319(9/30/2025), REJT0899(11/30/2025); CK000445/00801741101557/REJP2744(7/31/2025), REJR2662(9/30/2025); CK000687/00801741136535/REJP2746(6/30/2025), REJV3817(9/30/2025); CK000524A/00801741124068/REJP2748(6/30/2025), REJR1418(7/31/2025); CK000819/00801741152566/REJP2750(6/30/2025), REJS0294(6/30/2025); CK000266A/00801741185014/REJP2755(7/31/2025); 1174108D3/00801741154935/REJP4030(7/31/2025), REJR1272(9/30/2025), REJS1196(10/31/2025), REJS4633(7/31/2025); 3194108D/00801741027727/REJP4058(7/31/2025), REJS1304(5/31/2025); CK000545/00801741107399/REJP4222(1/31/2027), REJQ2267(2/28/2027); 1174108D5/00801741155147/REJQ0781(5/31/2025), REJQ1423(6/30/2025), REJS2164(6/30/2025), REJT0678(7/31/2025); 3174108D/00801741027581/REJQ0800(8/31/2025), REJQ1341(8/31/2025), REJR2656(9/30/2025); CK000775A/00801741188060/REJQ0807(8/31/2025), REJR1435(9/30/2025), REJS4754(10/31/2025), REJT0896(9/30/2025); 1194108D5/00801741155192/REJQ1441(6/30/2025), REJR1268(8/31/2025), REJS2058(7/31/2025), REJS3889(7/31/2025), REJT0862(7/31/2025); CK000736/00801741139499/REJQ1480(6/30/2025); CK000739/00801741139659/REJQ1601(6/30/2025), REJR2683(6/30/2025), REJS3894(8/31/2025), REJU1681(8/31/2025), REJV0873(8/31/2025), REJV3827(1/31/2026); 9194108/00801741028595/REJR0580(9/30/2025); 1194108/)00801741034503/REJR0596(9/30/2025), REJR2204(9/30/2025), REJS3533(10/31/2025); CK000660/00801741129650/REJR1419(9/30/2025), REJS1312(9/30/2025); CK000609A/00801741222504/REJR1654(6/30/2025); 9174108D/00801741035555/REJR1668(9/30/2025), REJR2230(9/30/2025); CK001067/00801741228711/REJR2202(8/31/2025), REJS3899(10/31/2025); CK000077D/00801741139598/REJR2231(9/30/2025); CK000882/00801741188794/REJS0259(8/31/2025), REJT0908(11/30/2025); CK000874/00801741178696/REJS0282(7/31/2025), REJS2188(6/30/2025), REJT1411(11/30/2025); CK000994/00801741215698/REJS0285(7/31/2025), REJS3572(8/31/2025); CK000870A/00801741184246/REJS3569(10/31/2025); CK000443C/00801741226557/REJT0880(10/31/2025); CK000668B/00801741228674/REJT1820(10/31/2025); CK000784/00801741189012/REJU0379(9/30/2025)
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1507-2025 | Class I | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.