Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns
Customed is recalling 402 units of Orthopedic Pack Basic (Code 900-2830) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Customed, Inc. is recalling 402 units of Orthopedic Pack Basic (Code 900-2830). The recall involves three specific lots: 140111332, 140211832, and 140412672. These surgical packs contain various items including absorbent towels, drapes, gowns, and instruments, and are EO sterilized.
The recall was initiated because Customed determined there is a possibility that the packaging integrity may be compromised. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients.
The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users should stop using the affected lots and contact the manufacturer for instructions.
The recalled product
- Product
- ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 1
- 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)
- Code 900-2830
- 3 lots 140111332 140211832 140412672
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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