[pending] Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Pending LLM rewrite. Source: FDA_DEVICE Z-2381-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Category
- Medical Device — Devices
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 (16)
- REF(Material)/UDI-DI/Lot(Batch): AK-12122-F/10801902197129
- 10801902193275
- 10801902197129
- 10801902168464/33F24B0184
- 33F24D0076
- 33F24F0321
- 33F24G0345
- 33F24K0111
- 33F25A0474
- 33F25C0915
- 33F25E0061
- 33F25E0924
- 33F25J0832
- 33F25L0404
- 33F26B0552
- 33F24A0102
Distribution
Distributed nationwide across the United States.
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