PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle
FDA Recall Z-1338-2018 · Posted None
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Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeNEW
Date Initiated2018-01-10
Date Terminated2019-04-11
Product Quantity7020
Reason for Recall
Three (3) lots were distributed with the incorrect expiry date on the label. The lots
were labeled with an expiry date of five (5) years from date of manufacture instead
of the correct expiry date of two (2) years from date of manufacture.
Firm Action
On January 10, 2018 an URGENT MEDICAL DEVICE LETTER for removal was issued to customers requesting that all affected personnel to discontinue use or distribution of the recalled product. The following actions being required:
1. Examine inventory and quarantine all affected product
2. Communicate this recall notice to all affected personnel at facility, or other affected facilities.
3. Complete the business reply form attached to the recall letter.
4. Keep the recall notice posted visibly at facility and maintain a copy with your records
5. Return unused product to recalling firm by April 13, 2018.
For further assistance contact 1-855-215-5039.
Root Cause
Process control
Distribution Pattern
Distribution US Nationwide, Canada, India, and Colombia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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