Reprocessed Diagnostic Electrophysiology recall: Sterility Concern
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104…
Why was Reprocessed Diagnostic Electrophysiology recalled?
Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot/Serial numbers: 1529652 1535548 1538579 1538655 1562418 1562420 1568434 1568478 1596050 1258475 1596051 1535068 1535071 1535072 1559331 1363123 1406041 1531413 1533378 1533385 1535540 1596047 1596048 1471197 1539560 1539561 1541119 1596049 757895 1600879 1520424 1558826 1558827 1600880 1600881 1558103 1434511 1464987 1600882 1313231 1600883 1600884 1401578 1570964 1600670 1600671
- Product
- Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104…
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 46 units total
- Distribution
- US Distribution: in the states of: Arizona, California, and Ohio.
- Recall date
- November 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)