Customed LABOR & DELIVERY PACK - Includes recall: Sterility Concern
Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY…
Why was Customed LABOR & DELIVERY PACK - Includes 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 900-168, 34 lots: 110061523 110092042 110092166 110092388 110112612 110123053 111010060 111020331 111041058 111051332 111061506 111071775 111082059 111102842 111113023 111123371 112072440 112083401 112114642 112125025 113026049 113036454 113036752 113057838 113078270 113088750 113089158 113109744 131110336 140111166 140211649 140211925 140513102 140513461
- Product
- Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY…
- Recalling firm
- Customed, Inc
- Quantity
- 34 lots; 2648 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)