CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
Codan Swan-lock Swabable Needlefree Connector recalled by Codan US
Codan US is recalling Codan Swan-lock Swabable Needlefree Connector, distributed in California, Michigan, New York, Pennsylvania, Virginia. The recall was initiated on 12 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2433-2020
- FDA event ID
- 85367
- Recalling firm
- Codan US, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Sep 2019
- FDA classified
- 26 Jun 2020
- Reported
- 8 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 12 Sep 2019 | Recall initiated by company | |
| 26 Jun 2020 | Classified by FDA | +288 days |
| 8 Jul 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Distribution was made to CA, MI, NY, PA, and VA. There was no military/government distribution. Foreign distribution was made to Canada, Australia, New Zealand, and Chile.
Questions about this recall
Is Codan Swan-lock Swabable Needlefree Connector recalled?
Yes. Codan US recalled Codan Swan-lock Swabable Needlefree Connector on 12 Sep 2019. The recall is Class II and its status is Terminated. Recall number Z-2433-2020.
Why was it recalled?
Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
Which lots are affected?
Lot number 78503
Where was it sold?
Distribution was made to CA, MI, NY, PA, and VA. There was no military/government distribution. Foreign distribution was made to Canada, Australia, New Zealand, and Chile.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |