Arrow paracentesis kit JHH contains drugs from a recalled supplier
The Arrow paracentesis kit, REF ASK-00376-JHH, is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 180 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 paracentesis kit, REF ASK-00376-JHH, UDI-DI 10801902193275, lots 33F25G0629 and 33F24K0592. The action covers 180 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 and lot numbers above, quarantine it, and follow the instructions issued by Arrow International.
The recalled product
- Product
- Description/REF: PARACENTESIS KIT/ASK-00376-JHH
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 180
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 (2)
- REF(Material)/UDI-DI/Lot(Batch): ASK-00376-JHH/10801902193275/33F25G0629
- 33F24K0592
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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