Codan Swan-Lock Needlefree Connectors Recalled for Potential Sterility Compromise
Codan US Corporation is recalling 34,776 units of Swan-Lock Swabable Needlefree Connectors because individual packages may have incomplete or bad seals that could compromise sterility.
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: The recall is classified as FDA Class II. The hazard involves a potential compromise of sterility in a medical device, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Codan US Corporation is voluntarily recalling 34,776 units of CODAN SWAN-LOCK Swabable Needlefree Connectors, Catalog #BC1000N, REF 16.7220. The recall is due to a quality control issue where individual packages of the connectors may have incomplete or bad seals. This defect could compromise the sterility of the medical devices.
The affected product is individually packaged, sterile, and sold in cases of 504 units. The specific lot number for this recall is 78503. The firm name on the label is CODAN US CORPORATION, located in Santa Ana, CA.
Distribution of the affected units was made to California, Michigan, New York, Pennsylvania, and Virginia. There was no military or government distribution. Foreign distribution was made to Canada, Australia, New Zealand, and Chile. Consumers and healthcare facilities should stop using the affected products and contact Codan US Corporation for further instructions or a return.
The recalled product
- Product
- CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA.
- Manufacturer
- Codan US Corporation
- Affected units
- 34,776
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 (1)
- Lot number 78503
Distribution
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