Arrow peritoneal lavage catheter kits contain recalled supplier drugs
The Arrow peritoneal lavage catheter kit, 8 Fr, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 7,560 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 the peritoneal lavage catheter kit, 8 Fr, REF AK-09000. The action covers 7,560 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, 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: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 7,560
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 (17)
- REF(Material)/UDI-DI/Lot(Batch): AK-09000/30801902121722
- 10801902193275
- 20801902121756/33F24B0178
- 33F24C0097
- 33F24E0336
- 33F24F0311
- 33F24G0335
- 33F24K0101
- 33F24L0795
- 33F25E0919
- 33F25G0467
- 33F25G0758
- 33F25H0722
- 33F25J0468
- 33F25L0463
- 33F26A0389
- 33F24A0368
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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