CLASS II ONGOING Device recall · Reported 24 Aug 2022 · FDA Enforcement Report
BD PhaSealTM Y-Site Connector (C80)- airtight recalled
Becton Dickinson & is recalling BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer, distributed nationwide in the US. The recall was initiated on 18 Jul 2022 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-1555-2022
- FDA event ID
- 90567
- Recalling firm
- Becton Dickinson &, Franklin Lakes, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jul 2022
- FDA classified
- 18 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 18 Jul 2022 | Recall initiated by company | |
| 18 Aug 2022 | Classified by FDA | +31 days |
| 24 Aug 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system. Catalog Number: 515304
Where it was distributed
US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX
Nationwide CaliforniaFloridaGeorgiaIllinoisMarylandMichiganPennsylvaniaPuerto RicoTennesseeTexas
Questions about this recall
Is BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer recalled?
Yes. Becton Dickinson & recalled BD PhaSealTM Y-Site Connector (C80)- airtight and leak-proof Closed System Drug Transfer on 18 Jul 2022. The recall is Class II and its status is Ongoing. Recall number Z-1555-2022.
Why was it recalled?
Incorrect expiration date listed on the product labels. The expiration date listed on the product label is beyond the expiration date of the product.
Which lots are affected?
UDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205
Where was it sold?
US Nationwide Distribution CA FL GA IL MD MI OR PA PR TN TX
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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