Arrow PICC and Delta kits contain drugs from recalled supplier
Arrow PICC and PICC/Delta kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 37,738 units are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
Arrow International is recalling PICC and PICC/Delta kits, covering REF ASK-44063-NS, ASK-45052-NS, ASK-45541-MHBV and ASK-45552-RH among the catalog numbers listed in the recall notice. The action covers 37,738 units.
Lidocaine, bupivacaine and 0.9% sodium chloride, the subject of a supplier recall, were included in the kits and sets. According to the manufacturer, 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. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States across a large number of states. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF numbers, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Arrow International.
The recalled product
- Product
- Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURV
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Category
- Medical Device — PICC kit
- Affected units
- 37,738
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF(Material)/UDI-DI/Lot(Batch): ASK-44063-NS/10801902193275/33F25F0100
- ASK-45052-NS/10801902193275/33F24L0864 ASK-45541-MHBV/10801902193275
- 10801902167696/33F25D0410
- 33F26C0012
- 33S24A0690
- 33F25B0574
- ASK-45552-RH/10801902193275/33F25B0575
- 33F25D0361
- 33F25F0197
- 33F25K0373
- 33F25A0082
- DLX-45552-CURVB/10801902193275
- 10801902208702/33F25E0506
- 33F25E0833
- 33F26C0038
- 33S24B0518
- 33F24L0982
- DLX-45552-CURVC/10801902193275
- 10801902208733/33F25B0386
- 33F25D0381
Distribution
Part of a larger recall action
This product is one of 35 recalled by ARROW INTERNATIONAL, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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