Surgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity
Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving potential sterile barrier integrity compromise on surgical equipment used in invasive procedures. No reported illnesses or injuries, but the hazard presents significant risk of serious infection if sterilization integrity has been affected.
Plain-English summary
Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit. The FDA issued the recall due to uncertainty regarding the integrity of the sterilization methods used to ensure the sterile barrier remains intact.
The affected product was distributed in North Carolina. The recall involves three lot numbers: 213639474, 212957814, and 212675717 (Part Number ZZ-0958; Primary DI Number M752ZZ09580).
Healthcare facilities and providers who have received affected lots should discontinue use immediately and contact Stradis Healthcare for product return and disposal instructions.
No illnesses or injuries have been reported to date. However, surgical sutures with compromised sterile barrier integrity could allow microbial contamination, potentially resulting in serious infection following surgical procedures.
The recalled product
- Product
- Surgical Suture Kit
- Manufacturer
- Stradis Healthcare
- Affected units
- 7,340
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Part Number: ZZ-0958
- Primary DI Number: M752ZZ09580
- Lot Numbers: 213639474
- 212957814
- 212675717
Distribution
Distributed in 1 state:
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