O.b. Pack recall: Sterility Concern
O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF (…
Why was O.b. Pack recalled?
Customed has determined that there is the possibility that packaging integrity may be compromised on differ 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 900-2002, 23 lots: 111113064 111123196 111123470 112010109 112041220 112051915 112062471 112083419 112093922 112104298 112114657 112125310 113015054 113015437 113067910 113088778 113089204 113099408 131110220 140111321 140211502 140211932 140312439
- Product
- O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF (…
- Recalling firm
- Customed, Inc
- Quantity
- 23 lots; 1396 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)