Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Arthroscopy Pack I units 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 (loss of sterility/contamination) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Customed, Inc. has initiated a recall of Arthroscopy Pack I (Product Code 900-2473) due to a determination that packaging integrity may be compromised on multiple catalog numbers. The affected product consists of EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall covers 4 lots totaling 972 units.
The recall is being conducted because the compromised packaging integrity could result in product contamination or a loss of sterility condition. This poses a risk of injury to patients who use the products. The affected lots are identified by the following codes: 112020354, 112051960, 112072724, and 113057469.
The affected 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. Users of these medical devices should contact Customed, Inc. for further instructions regarding the return or replacement of the recalled units.
The recalled product
- Product
- ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (1) U - DRAPE 60" X 70" WITAPE SPLIT 6 X 21 (1) SHEET SPLIT W/ADHESIVE 108" X 77" STD SMS (1) STOCKINETTE IMPERVIOUS
- 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 900-2473
- 4 lots 112020354 112051960 112072724 113057469
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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