Reported Jul 31, 2013 · Terminated
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating…
Ethicon Endo-Surgery Inc.
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: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Cincinnati, OH · 45242-2803
Is this the product you have?
- LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm
- M/L Product UsageThe LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique
- Lot codes and dates
838 of 838 products
Products covered by this recall # Product as published 1 H44Z7W, 37ER320, 01/03/12 to 11/15/16 2 J4A016, 37ER320, 01/05/12 to 12/15/16 3 J4A11G, 37ER320, 01/10/12 to 12/15/16 4 J4A124, 37ER320, 01/10/12 to 12/15/16 5 J4A145 37ER320, 01/11/12 to 12/15/16 J4A182, 37ER320, 01/13/12 to 12/15/16 6 J4A21T, 37ER320, 01/27/12 to 12/15/16 7 J4A28D, 37ER320, 01/19/12 to 12/15/16 8 J4A28U, 37ER320, 01/19/12 to 12/15/16 9 J4A335, 37ER320, 01/23/12 to 12/15/16 10 J4A38L, 37ER320, 01/25/12 to 12/15/16 11 J4A39D, 37ER320, 01/26/12 to 12/15/16 12 J4A406, 37ER320, 01/26/12 to 12/15/16 13 J4A40P, 37ER320, 02/07/12 to 12/15/16 14 J4A45T, 37ER320, 01/29/12 to 12/15/16 15 J4A461, 37ER320, 01/30/12 to 12/15/16 16 J4A46T, 37ER320, 01/30/12 to 12/15/16 17 J4A48U,), 37ER320, 02/02/12 to 12/15/16 18 J4A49L, 37ER320, 02/01/12 to 12/15/16 19 J4A525, 37ER320, 02/02/12 to 12/15/16 20 J4A535, 37ER320, 02/02/12 to 12/15/16 - Amount recalled
- 738,356
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
- Nationwide
- PR
Why it was recalled
Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
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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