Recall Z-1775-2013
Ethicon Endo-Surgery Inc · initiated April 12, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The 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.
Codes / lots: H44Z7W, 37ER320, 01/03/12 to 11/15/16; J4A016, 37ER320, 01/05/12 to 12/15/16; J4A11G, 37ER320, 01/10/12 to 12/15/16; J4A124, 37ER320, 01/10/12 to 12/15/16; J4A145 37ER320, 01/11/12 to 12/15/16 J4A182, 37ER320, 01/13/12 to 12/15/16; J4A21T, 37ER320, 01/27/12 to 12/15/16; J4A28D, 37ER320, 01/19/12 to 12/15/16; J4A28U, 37ER320, 01/19/12 to 12/15/16; J4A335, 37ER320, 01/23/12 to 12/15/16; J4A38L, 37ER320, 01/25/12 to 12/15/16; J4A39D, 37ER320, 01/26/12 to 12/15/16; J4A406, 37ER320, 01/26/12 to 12/15/16; J4A40P, 37ER320, 02/07/12 to 12/15/16; J4A45T, 37ER320, 01/29/12 to 12/15/16; J4A461, 37ER320, 01/30/12 to 12/15/16; J4A46T, 37ER320, 01/30/12 to 12/15/16; J4A48U,), 37ER320, 02/02/12 to 12/15/16; J4A49L, 37ER320, 02/01/12 to 12/15/16; J4A525, 37ER320, 02/02/12 to 12/15/16; J4A535, 37ER320, 02/02/12 to 12/15/16; J4A559, 41XBB48B 02/02/12 to 07/15/16; J4A60K, 37ER320, 02/08/12 to 01/15/17; J4A60W, 37ER320, 02/08/12 to 01/15/17; J4A61Z, 37ER320, 02/08/12 to 01/15/17; J4A62E, 37ER320, 02/08/12 to 01/15/17; J4A62U, 37ER320, 02/09/12 to 01/15/17; J4A71W, 37ER320, 02/15/12 to 01/15/17; J4A729, 37ER320, 02/15/12 to 01/15/17; J4A73H, 37ER320, 02/15/12 to 01/15/17; J4A743, 37ER320, 02/16/12 to…
Reason for recall
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
FDA-determined cause: Under Investigation by firm
Action taken
Ethicon sent an Urgent : Medical Device Recall letter dated April 30, 2013 to all primary and secondary consignees via overnight UPS to allow tracking of the receipt. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately and return affected products for credit. This credit is intended to facilitate replacement purchase. For questions contact your local representative or call Ethicon Customer Support Center at 1-877-384-4266 option 6.
Details
- Recall number
- Z-1775-2013
- Initiated
- April 12, 2013
- Posted by FDA
- July 19, 2013
- Terminated
- May 1, 2014
- Product code
- GDO – Applier, Surgical, Clip
- Quantity
- 738,356
- Distribution
- Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA…
- Recalling firm
- Ethicon Endo-Surgery Inc, Cincinnati, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1776-2013 Class II | LIGACLIP Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm…Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple… | 04/12/2013Terminated |
| Z-1777-2013 Class II | LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile…Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple… | 04/12/2013Terminated |