RecallRadar

FDA Device recall Z-1358-2015

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling

On 2015-04-08 the FDA classified a Class II recall of Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling by C R Bard, citing potential breach of the sterile barrier packaging.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1358-2015
ClassificationClass II
Statusterminated
Initiated2015-01-30
Published2015-04-08
Last updated2026-09-13 11:53 UTC
CompanyC R Bard
DistributionUS

Product

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671

Reason

Potential breach of the sterile barrier packaging.

Identifiers

code_infoLot Numbers NGYJ0603 and NGYJ1671

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1358-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.