STD KIT Gk260 recall
STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or…
Why was STD KIT Gk260 recalled?
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.
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 #: 1237620, 1238063
- Product
- STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or…
- Recalling firm
- Applied Medical Resources Corp
- Quantity
- N/A
- Distribution
- U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain
- Recall date
- April 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)