Central line insertion kits recalled after being sterilized more than once
American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.
What this means for you
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: Scored 3 under the risk-of-harm criterion: quality and safety cannot be confirmed for kits used in an invasive procedure, and no injuries are reported.
Plain-English summary
Medical convenience kits sold as ADULT CENTRAL LINE INSERTION SUPPLY KIT, item numbers UICL44P and UICL44R, are being recalled.
The identified products were re-gassed, meaning sterilized more than once, after a nonconformance occurred during the initial ethylene oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so product quality, safety and effectiveness cannot be confirmed for re-gassed product.
The recall covers 32,433 units in total, including UICL44P (UDI-DI 191072194268, lot 8003911) and UICL44R (UDI-DI 191072234018, lot 8317711). The product was distributed in South Dakota, Iowa, Minnesota, Washington and Illinois. The FDA has classified the action as Class II.
Facilities holding the listed lots should quarantine them and follow the firm's instructions rather than using the kits for central line placement.
The recalled product
- Product
- Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
- Manufacturer
- American Contract Systems Inc.
- Category
- Medical Device — Surgical kit
- Hazard
- resterilization
- unvalidated-process
- sterility-assurance
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 (2)
- UICL44P UDI-DI 191072194268 Lot 8003911 Bag serial number N/A
- then entire lot is affected
Distribution
Distributed nationwide across the United States.
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