Customed Recalls Hip Orthopedic Packs Due to Potential Sterility Loss
Customed, Inc. is recalling 36 units of Hip Orthopedic Packs because packaging integrity may be compromised, risking patient injury from 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are never scored below 4 (Severe).
Plain-English summary
Customed, Inc. is recalling 36 units of Hip Orthopedic Packs (Product Code 900-1835) due to a potential compromise in packaging integrity. The affected lots are 113109763, 131210771, and 140412619. These packs contain various surgical instruments, drapes, and supplies used in hip orthopedic procedures.
The recall was initiated because the compromised packaging could result in product contamination or a loss of sterility. This condition poses a risk of injury to patients who receive the products. The agency has classified this recall as Class I.
The products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Consumers and healthcare facilities should stop using these products and contact Customed, Inc. for instructions on return or replacement.
The recalled product
- Product
- HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER…
- 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)
- Product code 900-1835
- 3 lots: 113109763 131210771 140412619
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.
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