FDA Enforcement
Class II
Terminated
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Recall: Z-1278-2020
·
Reported February 26, 2020
Enforcement
- Recall Number
- Z-1278-2020
- Event ID
- 84769
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Covidien LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 26, 2020
- Initiation Date
- December 18, 2019
- Classification Date
- February 19, 2020
- Termination Date
- August 16, 2022
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908, United States
Description
Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Reason
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Code Info
Lot - A9H1065Y Expiration Date - 2024-07-31
Distribution
US Nationwide distribution.
Quantity
139,938 units total