Z-2378-2026Class I
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB...
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2026-04-21 / Open, Classified / root cause: manufacturing process
ARROW INTERNATIONAL, LLC began a recall of Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV... on . FDA classified it as Class I and gives the reason as "Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2378-2026
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-PK1A
- Product code
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Reason for recall
- Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- On 4/21/2026, correction notices (Firm Event Number: EIF-000608, lidocaine and bupivacaine) were mailed to customers who were asked to do the following: Arrow International LLC is voluntarily recalling product due to the Huons Co. Ltd. recall of Lidocaine and Bupivacaine, which is included in impacted Arrow Kits & Sets. Medical facilities 1. Provide this correction notice to all persons who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 2. Check your inventory for product within the scope of this Medical Device Notification and place a copy of this notice with all affected product. 3. Complete and return the response form virtually via: https://fca.myteleflex.com/en/recall/000608 Distributors: 1. Provide Medical Device Notification to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you as their distributor. 2. Check your inventory for affected product. Place a copy of this notification with all affected product and ensure that the notification is included with future distributions of affected product. 3. Complete and return the response form via link: https://fca.myteleflex.com/en/recall/000608 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by return email. If you have questions contact firm's Customer Service: Link: https://fca.myteleflex.com/en/recall/000608, Customer Service: Telephone: 1-866-396-2111, FAX: 1-855-419-8507 Email: [email protected] On 5/29/2026, additional amended notices (Firm Event Number: EIF-000608-01) were mailed to include additional affected devices. On 5/1/2026, additional notices (Firm Event Number: EIF-000609, sodium chloride) were mailed and emailed to customers who have 0.9% sodium chloride (10mL saline solution ampule) in kits and sets.
- Quantity in commerce
- 3,481
- Distribution
- US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
- Product codes and lots
- REF(Material)/UDI-DI/Lot(Batch): DLX-35563-HPKC/10801902193275/33F25D0520; ASK-44552-ABKB/10801902140798, 10801902216677/33X25K0002, 33S24A0529; ASK-45552-MHBV/10801902193275/33F25K0372, 33F25M0199, 33F26A1534, 33F24L0348; DLX-45541-HPKB/10801902193275, 10801902208849/33F25G0393, 33F25L0055, 33F26A1570, 33F24D0604; ASK-45052-MC/10801902216660/33S24A1242; CDC-44041-HPK1A/10801902193275/33F24K0430; CDC-44052-HPK1A/10801902193275/33F25D0241; CDC-44052-VPS2/10801902193275/33F25E0514; CDC-45063-HPK1A/10801902193275/33F25D0242; CDC-45541-VPS2/50801902120781, 10801902193275/33S24A0211, 33F25C0699; CDC-45552-VPS2/10801902193275/33F25E0704; ASK-45541-CHS/10801902193275/33F26A1422, 33F24L0897; ASK-45541-UOI2/10801902193275/33F24L0991; ASK-45552-CHS/10801902193275/33F26A1395, 33F25G0260; ASK-45552-UOI2/10801902193275/33F24L0431; ASK-45563-CHS/10801902193275/33F25A0199; ASK-42563-LTAC/10801902203271/33F24F0852; CDC-42541-JX1A/10801902193275/33F26A1469, 33F24J0135; CDC-42552-JX1A/10801902193275/33F25D0561, 33F24L0285; CDC-42563-JX1A/10801902193275, 10801902170863/33F25C0702, 33F25D0562, 33F25G0311, 33F25J0437, 33F24D0507; CDC-43052-JX1A/10801902193275/33F25M0062, 33F24J0120; CDC-43063-JX1A/10801902193275, 10801902188332/33F25G0003, 33F26B0805, 33F25D0240; CDC-05542-PK1A/10801902193275, 50801902116715/33F25H0436, 33F25H0576, 33F24D0325
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2363-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2364-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2365-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2366-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2367-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2368-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2369-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2370-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2371-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2372-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2373-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2374-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2375-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2376-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2377-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2378-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2379-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2380-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2381-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2382-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2383-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2384-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2385-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2386-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2387-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2388-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2389-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2390-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2391-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2392-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2393-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2394-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2395-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2396-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2397-2026 | 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.