Two Lead Arthroscopic Irrigation Set — Class II medical device recall Z-1683-2013
Terminated recall by Baxter Healthcare Corp., reported 2013-07-17, distributed nationwide. A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinhole
| Recall number | Z-1683-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2013-07-10 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2015-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 530,488 units |
| Reason classes | sterility |
Product
Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.
Reason for recall
A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
Machine access
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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.