Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed is recalling specific lots of HIP PACK I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.
Plain-English summary
Customed, Inc. is recalling four lots of HIP PACK I (2), code 900-2504, surgical convenient packs. The affected products include various surgical drapes, gowns, and utility items packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall involves 336 units distributed worldwide, including the United States (nationwide, Florida, Puerto Rico, USVI) and several international locations such as Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on these specific catalog numbers. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The affected lot numbers are 112020358, 112052030, 112072733, and 113078529.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products. The FDA has classified this as a Class I recall, 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
- HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE HIP 89" X 128" REINFORCE
- 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 (2)
- 900-2504
- 4 lots: 112020358 112052030 112072733 113078529
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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