Arrow epidural catheter kits contain drugs from a recalled supplier
Arrow epidural catheter and catheterization kits are being recalled because they contain lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,525,831 units 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 epidural catheter and epidural catheterization kits, covering REF ASK-05502-VM1, AK-05501, AK-05502 and AK-05502D among the catalog numbers listed in the recall notice. The action covers 1,525,831 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: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L;
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 1,525,831
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-05502-VM1/10801902210217
- 10801902209938/33F25C0168
- 33F25C0880
- 33F25E0202
- 33F25G0134
- 33F25H0126
- 33F26C0297
- 33F24C0216
- AK-05501/)10801902210217
- 10801902209501
- 10801902209518/33F24E0057
- 33F24E0058
- 33F24J0496
- 33F24K0094
- 33F24L0564
- 33F25A0460
- 33F25A0617
- 33F25C0728
- 33F25E0043
- 33F25E0913
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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