Z-2323-2023Class II
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-15 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number... on . FDA classified it as Class II and gives the reason as "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2323-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810; d. ECMO INSERTION BUNDLE W/O CANNULA, Model Number: CVI4915; e. FLOOR ULTRASOUND GUIDED IV SECUREMENT, Model Number: IVS3770; f. IV SECUREMENT KIT, Model Number: DYNDV2407A; g. MIDLINE BUNDLE 4FR SL, Model Number: MID0005; h. MIDLINE INSERTION TRAY, Model Number: CVI4340; i. MIDLINE KIT 4F SL MAX BARRIER STD, Model Number: MIDST04011; j. MIDLINE KIT 4F SL MB, Model Number: MID0001; k. MIDLINE KIT 4F SL PL MAX BARR, Model Number: DYNJ80141MB, MID0003; l. MIDLINE KIT 4F SL PL MB, Model Number: PICC0009A; m. MIDLINE KIT 5F DL PL MAX BARR, Model Number: DYNJ80152MB; n. NEONATAL PICC INSERTION TRAY, Model Number: DYNDA2509A, MNS8765; o. NEONATAL PICC LINE INSERTION TRAY, Model Number: DYNDC2120B; p. NICU PICC TRAY, Model Number: CVI3740A; q. PED ULTRASOUND GUIDED PIV, Model Number: IVS3990; r. PEDIATRIC PICC INSERTION TRAY, Model Number: CVI4450B; s. PERIPHERAL ULTRASOUND CATHETER INSERTION, Model Number: DYNDV2285, MNS9865; t. PICC BUNDLE 5FR DL, Model Number: PICC0013; u. PICC INSERTION BUNDLE, Model Number: DT14560; v. PICC INSERTION TRAY, Model Number: CVI3805, CVI3820; w. PICC KIT 4F SL PL MAX BARRIER, Model Number: DYNJ70141MB, PICC0010, PICC0011, PICC0012; x. PICC KIT 5F DL PL MB, Model Number: DYNJ70152MB; y. PIV BSI KIT, Model Number: BSIPIV1010; z. PIV KIT, Model Number: BSIPIV1004; aa. POLY MIDLINE KIT 4F SL, Model Number: DYNJ68937A; bb. QUINTEN CATH ACCESSORY KIT, Model Number: CVI3700; cc. ULTRASOUND GUIDED IV KIT, Model Number: IVS3705, IVS3705A, IVS3905A; dd. ULTRASOUND GUIDED IV SECUREMENT SET, Model Number: IVS3350; ee. ULTRASOUND GUIDED IV START KIT, Model Number: DYNDV2465, DYNDV2518, DYNDV2547; ff. ULTRASOUND GUIDED IV START KIT W/SHIELD, Model Number: BSIPIV1006; gg. ULTRASOUND GUIDED IV/MIDLINE KIT, Model Number: DYNDV2385; hh. ULTRASOUND GUIDED PIV, Model Number: IVS4075; ii. ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG, Model Number: BSIPIV1011; jj. ULTRASOUND GUIDED PIV INSERTION KIT, Model Number: IVS3485A, IVS3840, IVS3840A, IVS3940, IVS3940A, IVS3940B; kk. ULTRASOUND GUIDED PIV KIT, Model Number: BSIPIV1005, DYNDA2669, IVS3300, IVS3420A, IVS3420B, IVS3495, IVS3505, IVS3655B, IVS3900, IVS3900A, IVS4005; ll. ULTRASOUND GUIDED PIV START KIT, Model Number: IVS3715; mm. ULTRASOUND IV START KIT, Model Number: IV8790; nn. ULTRASOUND PIV BUNDLE, Model Number: IV8635A, IV8635B, IV8635C; oo. ULTRASOUND PIV KIT, Model Number: IVS3970; pp. UNIVERSAL BUNDLE-CENTRAL LINE PACK, Model Number: CVI3910; qq. UNIVERSAL LINE INSERTION TRAY, Model Number: DT16125; rr. USG IV START KIT, Model Number: DYNDV2435; ss. USG PIV KIT, Model Number: DYNDV2536, DYNDV2567; tt. USGPIV Insertion Kit, Model Number: MBSIULSGD01; uu. USGPIV KIT, Model Number: DYNDV2578; vv. USPIV KIT, Model Number: IVS3910; ww. VAMC PICC PREP BUNDLE, Model Number: CVI3880; xx. VANTEX 7FR 3L 16CM CVC INSERTION BNDL, Model Number: STCVC2020A; yy. VANTEX 7FR 3L 20CM CVC INSERTION BNDL, Model Number: STCVC2015A; zz. VI PACK, Model Number: DYNJ64871
- Product code
- LRS I.V. Start Kit
- Reason for recall
- Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.
- Quantity in commerce
- 218,163 kits
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
- Product codes and lots
- All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNDA2482, UPC Number: 10193489198188. b. Model Number: ART920, UPC Number: 10653160327899. c. Model Number: DT19810, UPC Number: 10653160285656. d. Model Number: CVI4915, UPC Number: 10653160355489. e. Model Number: IVS3770, UPC Number: 10653160328230. f. Model Number: DYNDV2407A, UPC Number: 019348981701. g. Model Number: MID0005, UPC Number: 10653160349181. h. Model Number: CVI4340, UPC Number: 10653160309475. i. Model Number: MIDST04011, UPC Number: 10653160350699. j. Model Number: MID0001, UPC Number: 10193489381627. k. Model Number: DYNJ80141MB, UPC Number: 10889942733415; Model Number: MID0003, UPC Number: 10653160349334. l. Model Number: PICC0009A, UPC Number: 10193489760231. m. Model Number: DYNJ80152MB, UPC Number: 10889942733422. n. Model Number: DYNDA2509A, UPC Number: 10193489196986; Model Number: MNS8765, UPC Number: 10653160270515. o. Model Number: DYNDC2120B, UPC Number: 10193489198270. p. Model Number: CVI3740A, UPC Number: 10653160324416. q. Model Number: IVS3990, UPC Number: 10653160345282. r. Model Number: CVI4450B, UPC Number: 10653160358428. s. Model Number: DYNDV2285, UPC Number: 10193489194548; Model Number: MNS9865, UPC Number: 10653160294436. t. Model Number: PICC0013, UPC Number: 10653160351818. u. Model Number: DT14560, UPC Number: 10653160236887. v. Model Number: CVI3805, UPC Number: 10653160265085; Model Number: CVI3820, UPC Number: 10653160273509. w. Model Number: DYNJ70141MB, UPC Number: 10889942722808; Model Number: PICC0010, UPC Number: 10653160349112; Model Number: PICC0011, UPC Number: 10653160350842; Model Number: PICC0012, UPC Number: 10653160350491. x. Model Number: DYNJ70152MB, UPC Number: 10889942722822. y. Model Number: BSIPIV1010, UPC Number: 10653160356523. z. Model Number: BSIPIV1004, UPC Number: 10193489198843. aa. Model Number: DYNJ68937A, UPC Number: 10193489111545. bb. Model Number: CVI3700, UPC Number: 10653160259763. cc. Model Number: IVS3705, UPC Number: 10653160325819; Model Number: IVS3705A, UPC Number: 10653160342885; Model Number: IVS3905A, UPC Number: 10653160344391. dd. Model Number: IVS3350, UPC Number: 10653160313045. ee. Model Number: DYNDV2465, UPC Number: 10193489110166; Model Number: DYNDV2518, UPC Number: 019532708907; Model Number: DYNDV2547, UPC Number: 10653160354246. ff. Model Number: BSIPIV1006, UPC Number: 10653160356936. gg. Model Number: DYNDV2385, UPC Number: 10193489195217. hh. Model Number: IVS4075, UPC Number: 10653160350545. ii. Model Number: BSIPIV1011, UPC Number: 10653160353317. jj. Model Number: IVS3485A, UPC Number: 10653160328612; Model Number: IVS3840, UPC Number: 10653160341994; Model Number: IVS3840A, UPC Number: 10653160344612; Model Number: IVS3940, UPC Number: 10653160342304; Model Number: IVS3940A, UPC Number: 10653160345664; Model Number: IVS3940B, UPC Number: 10653160355335. kk. Model Number: BSIPIV1005, UPC Number: 10193489198867; Model Number: DYNDA2669, UPC Number: 10193489191912; Model Number: IVS3300, UPC Number: 10653160307662; Model Number: IVS3420A, UPC Number: 10653160342205; Model Number: IVS3420B, UPC Number: 10653160359067; Model Number: IVS3495, UPC Number: 10653160316596; Model Number: IVS3505, UPC Number: 10653160323761; Model Number: IVS3655B, UPC Number: 10653160358107; Model Number: IVS3900, UPC Number: 10653160344810; Model Number: IVS3900A, UPC Number: 10653160347774; Model Number: IVS4005, UPC Number: 10653160346142. ll. Model Number: IVS3715, UPC Number: 10653160326298. mm. Model Number: IV8790, UPC Number: 019348936055. nn. Model Number: IV8635A, UPC Number: 10653160324010; Model Number: IV8635B, UPC Number: 10653160327622; Model Number: IV8635C, UPC Number: 10653160344858. oo. Model Number: IVS3970, UPC Number: 10653160343431. pp. Model Number: CVI3910, UPC Number: 10653160272311. qq. Model Number: DT16125, UPC Number: 10653160254751. rr. Model Number: DYNDV2435, UPC Number: 019532704366. ss. Model Number: DYNDV2536, UPC Number: 10653160353676; Model Number: DYNDV2567, UPC Number: 10653160356455. tt. Model Number: MBSIULSGD01, UPC Number: 10193489199482. uu. Model Number: DYNDV2578, UPC Number: 10653160358374. vv. Model Number: IVS3910, UPC Number: 10653160338871. ww. Model Number: CVI3880, UPC Number: 10653160272755. xx. Model Number: STCVC2020A, UPC Number: 10653160350569. yy. Model Number: STCVC2015A, UPC Number: 10653160350552. zz. Model Number: DYNJ64871, UPC Number: 019348922536.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2290-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2291-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2292-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2293-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2294-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2295-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2296-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2297-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2298-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2299-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2300-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2301-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2302-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2303-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2304-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2305-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2306-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2307-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2308-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2309-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2310-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2311-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2312-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2313-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2314-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2315-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2316-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2317-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2318-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2319-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2320-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2321-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2322-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2323-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2324-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2325-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2326-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2327-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2328-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2329-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2330-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2331-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2332-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2333-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2334-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2335-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2336-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2337-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2338-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2339-2023 | Class II | 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.