medfusion Stopcock devices recalled due to sterility assurance deficiency
Smiths Medical is recalling over 933,000 medfusion Stopcock medical devices internationally due to lack of sterility assurance. The devices may not meet required sterility standards.
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: FDA Class II recall involving a medical device with a significant sterility assurance defect. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed. Per the severity rubric, sterility-assurance defects without reported illness are classified as High severity.
Plain-English summary
Smiths Medical ASD Inc. is recalling 933,518 medfusion Stopcock medical devices (1-way and 4-way models) due to lack of sterility assurance. These devices are components used in patient infusion systems.
The affected devices were distributed internationally to healthcare facilities in Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland. Specific model numbers and serial numbers are listed in the FDA recall notice.
The devices may not meet required sterility standards. Sterility assurance is critical for medical devices used in patient care, and the affected units may pose a risk if used without verification of their sterility.
The recalled product
- Product
- medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-10
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- sterility-assurance
- microbial-contamination
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 (20)
- a. 081-101BE
- Serial Numbers: 1570340901
- 1570344401
- 1570344402 b. 081-101GE
- Serial Numbers: 1570343301 c. 081-101GEE
- Serial Numbers: 1470293701
- 1570343401 d. 081-101NE
- Serial Numbers: 1570323801
- 1570341001
- 1570342701
- 1570344101
- 1660688101
- 1670354301 e. 081-102NE
- Serial Numbers: 1660636701 f. 081-102RE
- Serial Numbers: 1660636601 g. 089-101E
- Serial Numbers: 1570316801
- 1570342601
- 1570344601
- 1660670001
- 1670347801
Distribution
Distribution scope not specified by the agency.
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