CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
Polysorb Braided Absorbable Suture 0 30" Violet GU recalled by Covidien
Covidien is recalling Polysorb Braided Absorbable Suture 0 30" Violet GU-46, distributed nationwide in the US. The recall was initiated on 18 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1298-2020
- FDA event ID
- 84769
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Dec 2019
- FDA classified
- 19 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 18 Dec 2019 | Recall initiated by company | |
| 19 Feb 2020 | Classified by FDA | +63 days |
| 26 Feb 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Polysorb Braided Absorbable Suture 0 30" Violet GU-46 recalled?
Yes. Covidien recalled Polysorb Braided Absorbable Suture 0 30" Violet GU-46 on 18 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1298-2020.
Why was it recalled?
There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.
Which lots are affected?
Lot - D7H0796X Expiration Date - 2022-08-31
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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