Recall Z-2889-2016 ยท KDC Instrument, Surgical, Disposable
Ethicon, Inc.
ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
| Date | Aug 1, 2016 |
| Status | Terminated |
| Reason | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert. |
| Root cause | Other |
| Action | Ethicon Inc. sent an Urgent - Medical Device Correction Notification dated August 1, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this correction on hand and locate such product(s). Refer to Attachment 2 for the Product Identification Tool to identify the products that are subject to this correction by using package labels. 2. Please read Attachment 1 included within this letter thoroughly - MERSILENE" Tap |
| Quantity | 396,024 eaches |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.