Date Initiated by Firm | August 01, 2016 |
Create Date | September 27, 2016 |
Recall Status1 |
Terminated 3 on November 29, 2017 |
Recall Number | Z-2889-2016 |
Recall Event ID |
74901 |
Product Classification |
Instrument, surgical, disposable - Product Code KDC
|
Product | ETHICON MERSILENE" Tape
(also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) |
Code Information |
All unexpired lots MERSILENE" RS20 MERSILENE" RS21 MERSILENE" RS22 MERSILENE" RS23 MERSILENE" D10076 MERSILENE" D10117 MERSILENE" D5789 MERSILENE" D7164 MERSILENE" D8014 MERSILENE" D8062 MERSILENE" D8113 MERSILENE" D9212 |
Recalling Firm/ Manufacturer |
Ethicon, Inc. US Highway 22 West Somerville NJ 08876
|
For Additional Information Contact | 908-218-0707 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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" Tape Instructions for Use (IFU).
3. Ensure all users are aware of the issue by distributing this notice to all users of the Ethicon MERSILENE" Tape devices in your facility.
4. Replace the existing incorrect MERSILENE" Suture Instructions for Use (IFU) with the MERSILENE"Tape Instructions for Use (IFU) provided in Attachment 1 and dispose of the incorrect MERSILENE" Suture Instructions for Use (IFU) per your internal procedures.
5. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email it to Stericycle at 1- (866) 723-2836 or Ethicon8698@stericycle.com within three (3) business days. Please return the BRF even if you do not have product subject to this correction.
6. Keep this notice visibly posted with product subject to this correction in your facility for awareness.
For further questions, please call (908) 218-0707. |
Quantity in Commerce | 396,024 eaches |
Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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