Reported Jun 3, 2020 · Terminated
Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
Applied Medical Resources Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
Epix latis GRASPER5 mm x 35 cmREF C4130
- Qty10, Sterile R, CE, Rx ONLY
- UDI(01)00607915110147
- Lot codes and dates
14 of 14 products
Products covered by this recall # Product as published 1 1364578/Expiration Date: July 28, 2022 2 Batch: 1366453/Expiration Date: August 13, 2022 3 Batch: 1371249/Expiration Date: October 3, 2022 4 Batch: 1373050/Expiration Date: October 23, 2022 5 Batch: 1373248/Expiration Date: November 4, 2022 6 Batch: 1373249/Expiration Date: November 11, 2022 7 Batch: 1373255/Expiration Date: November 18, 2022 8 Batch: 1373260/Expiration Date: November 19, 2022 9 Batch 10 1373261/Expiration Date: November 24, 2022 11 Batch: 1373262/Expiration Date: December 2, 2022 12 Batch: 1373263/Expiration Date: December 5, 2022 13 Batch: 1377363/Expiration Date: December 11, 2022 14 Batch: 1377364/Expiration Date: December 17, 2022 - Amount recalled
- 32,760 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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