BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482
FDA Recall Z-1109-2021 · Posted None
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMF
Date Initiated2020-12-23
Date Terminated2022-11-21
Product Quantity155,200 needles
Reason for Recall
The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.
Firm Action
On 01/13/2020 BD issued an Urgent Medical Device Recall notices to distributors via letters and via e-mail. Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributors customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter will be provided to distributors, in the case they opt to contact their customers directly.
Root Cause
Process control
Distribution Pattern
Distribution US nationwide and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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