Reported Jun 19, 2013 · Terminated
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON…
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?
- ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments'¿" lock-out feature is designed to prevent a used reload from being refired.
- Lot codes and dates
- The following lot numbers and associated expiration
- dates are affected by this recall
J4AY8Z 5/15/2013J4C00J 6/15/2013J4C87R 7/15/2013J4CC1F 8/15/2013J4CD2X 8/15/2013J4CF3D 9/15/2013J4CJ0E 9/15/2013J4CJ78 9/15/2013J4CK2P 9/15/2013J4CM9X 10/15/2013J4CR2H 10/15/2013J4CT5H 11/15/2013J4CU86 11/15/2013J4CV1W 11/15/2013J4CV5H 11/15/2013K4C149 12/15/2013K4C17W 12/15/2013K4C33U 12/15/2013K4C41C 12/15/2013K4C600 1/15/2014K4C64A 1/15/20144C728 1/15/2014K4C82K 1/15/2014K4C88F 1/15/2014K4C94W 1/15/2014K4CC0L 2/15/2014CC8L 2/15/2014K4CD1E 2/15/2014K4CF1P 2/15/2014K4CF5D 2/15/2014K4CG18 3/15/2014K4CG4J 3/15/2014K4CG8P 3/15/2014K4CH44 3/15/2014K4CK0W 3/15/2014
- Amount recalled
- 57,540 Units
Where it was sold
- Nationwide
- PR
Why it was recalled
Ethicon Endo-Surgery is initiating a voluntary worldwide recall for ECHELON 60mm Black Reload (ECR60T) due to the potential for incomplete staple line formation from reload damage during the firing sequence.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ethicon Endo-Surgery Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.