Guarded Luer Connectors Recalled for Compromised Sterility in Blister Packaging
International Medical Industries recalls 228,000 Prep-Fill Guarded Luer Connectors due to unsealed blister packages compromising product sterility. The Class II recall affects medical devices distributed nationwide.
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 medical device recall with compromised sterility assurance on a critical medical connector. While no illnesses or injuries have been reported, unsealed packaging on sterile medical devices presents a direct risk of contamination and infection, meeting the criteria for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
International Medical Industries, Inc. is recalling 228,000 Prep-Fill Guarded Luer Connectors (GLC) due to blister package defects that compromise sterility assurance. The affected devices include Part Numbers 57-400, 57-400W, 57-401, 57-402, and 57-403 in multiple lot numbers specified by the manufacturer.
The devices were distributed nationwide to healthcare facilities in 27 states: Arkansas, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Texas, and Virginia. No government, military, or foreign distribution occurred.
Guarded Luer Connectors are sterile medical devices used in healthcare settings. An unsealed edge on the blister packaging can compromise the sterility barrier, potentially exposing the connectors to contamination. Patients or healthcare providers who have these devices should contact International Medical Industries for instructions on return or replacement.
This is a Class II recall by the FDA. Healthcare facilities and medical professionals should cease use of affected lot numbers and implement verification procedures to prevent inadvertent use of recalled devices.
The recalled product
- Product
- Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Co
- Manufacturer
- International Medical Industries, Inc.
- Hazard
- sterility-compromise
- contamination-risk
- packaging-defect
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 (19)
- a. Part 57-400 - Lot numbers 45266
- 44549
- 44120
- 43800
- 43626
- 42634
- 42236
- 39350
- 37176
- 36596
- 33074. UDI: B212574001. b. Part 57-400W - Lot numbers 39371
- 37093
- 37086
- 37079
- 39378
- 39364
- 39357
- 36558. UDI: B21257400W1. c. Part 57-401 - Lot numbers 45047
- 43633. UDI: B212574011. d. Part 57-402 - Lot number 37151. UDI: B212574021.
Distribution
Distributed nationwide across the United States.
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