PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
Reported: April 18, 2018 Initiated: January 10, 2018 #Z-1340-2018
Product Description
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle
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.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 180
- Distribution
- Distribution US Nationwide, Canada, India, and Colombia.
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle. Recalled by Ethicon, Inc.. Units affected: 180.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 18, 2018. Severity: Moderate. Recall number: Z-1340-2018.
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