RecallRadar

FDA Device recall Z-1572-2015

1/4 in

On 2015-05-13 the FDA classified a Class II recall of 1/4 in by Stryker Instruments Div, citing stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1572-2015
ClassificationClass II
Statusterminated
Initiated2015-03-26
Published2015-05-13
Last updated2026-09-13 11:53 UTC
CompanyStryker Instruments Div
DistributionUS

Product

1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.

Reason

Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging

Identifiers

code_infoPart Number:0225-019-000 and lot numbers: 10111012 11018012 11273012 12296012 13066012 13175012 14029012 14143012 10131012 11115012 12237012

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-1572-2015%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.