Customed Laparoscopy convenience pack include multiple recall: Sterility Concern
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes…
Why was Customed Laparoscopy convenience pack include multiple recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code 900-028, 30 lots: 111071871 112041386 112041433 112051660 112051712 112062301 112062560 112093834 112124408 112124903 112125312 113015686 113026162 113036772 113047331 113057830 113068022 113068136 113078564 113089015 113089177 113099559 131110062 131110395 131110575 140111089 140111447 140211739 140312327 140513052
- Product
- Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes…
- Recalling firm
- Customed, Inc
- Quantity
- 30 lots, 6977 units (multiple units per lot)
- Distribution
- 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.
- Recall date
- September 10, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)