Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPER...

FDA Device Recall #Z-2384-2014 — Class I — May 20, 2014

Recall Summary

Recall Number Z-2384-2014
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 51 lots; 11070 units (multiple units per lot)

Product Description

PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) TUBE SUCTION CONNECT~~~ X 12' LIF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (2) DRAPE SHEET 42" X 55" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP

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 900-1296, 51 lots: 110102576 110112604 110112865 110122889 110123065 111010033 111020358 111030562 111030827 111030934 111041085 111051267 111051325 111061488 111061600 111061645 111072036 111082183 111082197 111092481 111102671 111112927 111123333 112010033 112010243 112020326 112030613 112041246 112041437 112062581 112114631 112124934 112125280 113015634 113025909 113036727 113047212 113047323 113068143 113078567 113078691 113089183 113109718 131110066 131110595 131210958 140111405 140211870 140412595 140412882 140513344

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.

More from Customed, Inc Recalls by Firm Recall Reasons Device Safety Stats