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PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and ...

FDA Device Recall #Z-2576-2015 — Class II — July 10, 2015

Recall Summary

Recall Number Z-2576-2015
Classification Class II — Moderate risk
Date Initiated July 10, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Customed, Inc
Location Fajardo, PR
Product Type Devices
Quantity 508 packs

Product Description

PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

Reason for Recall

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Distribution Pattern

Distributed Only in Puerto Rico.

Lot / Code Information

Code:9001296 Lots: 140915095 exp. 2/28/19 141115975 exp. 11/30/15 150116734 exp. 1/31/16 150116736 exp. 2/28/16 150116737 exp. 2/28/16 150116739 exp. 2/28/16 150116738 exp. 2/28/16 150116735 exp. 2/28/16 150217232 exp. 2/28/16 150217230 exp. 2/28/16 150217233 exp. 2/28/16 150217234 exp. 3/31/16 150217235 exp. 3/31/16 150217231 exp. 3/31/16 150317683 exp. 3/31/16 150317684 exp. 3/31/16 150317685 exp. 3/31/16 150317686 exp. 4/30/16 150317687 exp. 4/30/16 150418285 exp. 4/30/16 150418286 exp. 4/30/16 150418287 exp. 4/30/16 150418288 exp. 4/30/16 150418289 exp. 4/30/16 150518634 exp. 5/31/16 150518635 exp. 5/31/16 150519022 exp. 5/31/16 150519023 exp. 5/31/16

Other Recalls from Customed, Inc

Recall # Classification Product Date
Z-1458-2016 Class II Catalog Number: 900277 SUCTION CATHETER TRAY ... Jan 7, 2016
Z-1464-2016 Class II Catalog Number: 9002940 OBSTETRICAL SURGICAL ... Jan 7, 2016
Z-1398-2016 Class II Catalog Number: 900010 SUTURE REMOVAL KIT Use... Jan 7, 2016
Z-1439-2016 Class II Catalog Number: 9001933 OPHTALMIC SURGICAL PA... Jan 7, 2016
Z-1433-2016 Class II Catalog Number: 900169 UNIVERSAL SURGICAL PAC... Jan 7, 2016

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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