Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 30 lots of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Customed, Inc. is recalling 30 lots of EO sterilized Cesarean Packs, product code 900-403. The recall involves 4,396 units distributed worldwide, including the United States (nationwide, including Puerto Rico and USVI) and several international locations such as Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was initiated because Customed determined that there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in an injury to the patient due to product contamination or loss of sterility condition. The affected lots are identified by specific lot numbers ranging from 112020525 to 140513246.
Healthcare facilities and consumers should stop using the affected products and contact Customed, Inc. for further instructions or a refund. The recall is classified as FDA Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST.…
- 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 900-403
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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