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

Lot, batch or date codesUDI-DI: 30382905153045 Lot Numbers: 2007212, 2103205
Quantity recalled9,340 units

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

Timeline

18 Jul 2022Recall initiated by company
18 Aug 2022Classified by FDA+31 days
24 Aug 2022Published 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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