Customed Recalls OB Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling OB Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling OB Packs, which are EO sterilized surgical convenient packs containing various obstetric and surgical supplies. The recall involves 18 lots and 1,580 units. The company determined that there is a possibility that packaging integrity may be compromised on different catalog numbers.
The compromised packaging could result in an injury to the patient due to product contamination or loss of sterility condition. The affected products were distributed worldwide, including in the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
Consumers and healthcare facilities should stop using the affected OB Packs and contact Customed, Inc. for further instructions or a return. The specific product code is 900-1030, and the recall number is Z-2367-2014.
The recalled product
- Product
- OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (2) PAD OBSTETRICAL X-LARGE
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product code 900-1030
Distribution
Part of a larger recall action
This product is one of 233 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 233 products in this recall →Related recalls
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