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ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD L...

FDA Device Recall #Z-2345-2014 — Class I — May 20, 2014

Recall Summary

Recall Number Z-2345-2014
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 1 lot; 120 units (multiple units per lot)

Product Description

ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) TUBE SUCTION CONNECT ~" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK L/F (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) NEEDLE HYPODERMIC 21G X 1Y2 LIF (1) NEEDLE SPINAL ANESTH 18G X 3 Y2 LIF (1) PAD ABDOMINAL 8" X 7.5" LIF (2) ELASTIC BANDAGE WITH VELCRO 6" X 5yds LIF (1) TIME OUT BEACON NON WOVEN LIF (1) NEEDLE HYPODERMIC 18G X 1 Y2 L/F (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF (1) COVER TABLE 44" X 90" LIF (1) COUNTER NDLIBLADE 20C FOAM/MAG L/F (3) TOWELS ABSORBENT 15" X 20" LIF (1) BAG SUTURE FLORAL (1) SHEET DRAPE 70" X 1 00" SMS LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE AAMI (1) TUR Y SET 81"2.1M REGULAR CLAM LIF LEVEL Ill TOWEL/WRAP LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" UF (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill LIF 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

Product code 900-740A, 1 lots: 140312021

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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