Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Reported: February 26, 2020 Initiated: December 18, 2019 #Z-1289-2020
Product Description
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Reason for Recall
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Details
- Recalling Firm
- Covidien LLC
- Units Affected
- 139,938 units total
- Distribution
- US Nationwide distribution.
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.. Recalled by Covidien LLC. Units affected: 139,938 units total.
Why was this product recalled? ▼
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Moderate. Recall number: Z-1289-2020.
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