MiniCap with Povidone-Iodine Solution — Class II medical device recall Z-1269-2015
Completed recall by Baxter Healthcare Corp., reported 2015-03-25, distributed nationwide. Product may have separating or protruding sponges
| Recall number | Z-1269-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-01-22 |
| Classified | 2015-03-13 |
| Reported by FDA | 2015-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, ES, NO, PT, SA |
| Quantity | 4,391,520 units |
| Lot numbers | GD896837, GD896845, GD896936, GD896944, GD897124, GD897157, GD897165, GD897371 |
| Model numbers | 5C4466P |
| Expiration dates | 2015-10, 2015-11, 2015-12, 2016-01 |
Product
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Reason for recall
Product may have separating or protruding sponges
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1269-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.