RecallRadar

FDA Device recall Z-2062-2015

0210-312-000-Woundcare Replacement kit with soft tip

On 2015-07-22 the FDA classified a Class II recall of 0210-312-000-Woundcare Replacement kit with soft tip by Stryker Instruments Div, citing potential sterility breach in the packaging.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2062-2015
ClassificationClass II
Statusterminated
Initiated2015-05-08
Published2015-07-22
Last updated2026-09-13 11:53 UTC
CompanyStryker Instruments Div
DistributionUS

Product

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

Reason

Potential sterility breach in the packaging.

Identifiers

code_info
0210-312-000: 12138012, 12203012, 12229012, 12256012, 12293012, 12314012, 12338012, 13086012, 13140012, 13192012; 0210…0210-312-000: 12138012, 12203012, 12229012, 12256012, 12293012, 12314012, 12338012, 13086012, 13140012, 13192012; 0210-318-000: 14140012,14258012; 0210-318-100: 12294012,13051012; 0210-318-200: 12143012, 12293012, 13066012, 14037012, 14112012

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-2062-2015%22

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