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SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4"...

FDA Device Recall #Z-2505-2014 — Class I — May 20, 2014

Recall Summary

Recall Number Z-2505-2014
Classification Class I — Serious risk
Date Initiated May 20, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Customed, Inc
Location Fajardo, PR
Product Type Devices
Quantity 6 lots, 171 units (multiple units per lot)

Product Description

SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWELS ABSORBENT 15" X 20" LIF (2) TUBE SUCTION CONNECT" X 12' LIF (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) BAG SUTURE FLORAL (1) SYRINGE 20cc W/0 NEEDLE LUER/LOCK LIF (1) SCALPEL WEIGHTED SAFETY #11 (1) NEEDLE SPINAL ANESTH 18G X 3% LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) CHLORAPREP 26ML APLICATOR TEAL LIF (2) ATTACHABLE POUCH BEACH CHAIR 35" X 43" WITH SUCTION PART (4) DRAPE UTILITY WITAPE L/F (4) STERI-DRAPE SMALL TOWEL DRAPE NPN-STERILE 17" X 11" LIF (1) BOWL UTILITY 32oz. (1) STOCKINETTE 6" X 48" L/F (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 24" X 24" (1) NEEDLE HYPODERMIC 22G X 1 % (1) GOWN SURG REINFORCED X-LARGE TOWEL I WRAP (1) GOWN MICROCOOL IMPERV. EXTRA LONG X-LARGE (2) DRAPE ORTHOPEDIC SPLIT (1) MAYO STAND COVER REINFORCED LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Reason for Recall

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Distribution Pattern

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

Lot / Code Information

Code 900-2766, 6 lots 113078317 131110257 131210801 140111215 140312143 140412666

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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