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Terminated

SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A303414A, A303416A, A303418A, A304400A, A304714A, A304716A, A304718A, A304914, A304916, A304918, A307414A, A307416A, A319414AM, A319416A, A319416AM, A319418AM, A319514AM, A319516A, A319516AM, A333100A, A333416A, A339414AM, A339516AM, A339516AM, A344916, A800064, A800065, A800364, A800365, A800366, A900216, A900416, A901216, A902114, A902216, A902414, A902416, A902418, A902616, A902914, A902916, A902918, A903314A, A903316A, A903318A, A903416A, A904100, A904400A, A909116M, A909216M, A919416AM, A919516AM, A942206, A942208, A942210, A942212, A942214, A942216, A942218, A942616, A942618, A943214, A943216, A943218, MTA902416 Product Usage catheter

FDA Recall Z-0803-2019 · Posted 2019-02-06

Recalling FirmBard Medical Division
Recall StatusTerminated
Product CodeMJC
Date Initiated2018-12-13
Date Terminated2020-11-02
Product Quantity883,171 units

Reason for Recall

potential for urine leakage around the vent on the vented sample port

Firm Action

Bard sent a Medical Device Notification letter dated December 13, 2018 to affected customers. The letter identified the affected product, problem nd actions to be taken. The distributors were instructed to forward the notice to their affected consignees.

Root Cause

Device Design

Distribution Pattern

US, Canada, UAE

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K910318BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETERC.R. Bard, Inc. · 1994-08-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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