Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 39 lots of arthroscopy 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 text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a score of 5 (Critical).
Plain-English summary
Customed, Inc. is recalling 39 lots of Arthroscopy Packs (Product Code 900-1832) due to a potential compromise in packaging integrity. The recalled items are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves 600 units distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI) and international locations such as Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.
The recall was initiated because the company determined 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 the loss of the product's sterility condition. The agency has classified this recall as Class I.
Healthcare facilities and consumers who have these specific arthroscopy packs should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should contact the manufacturer or their medical supply provider for guidance on handling the affected lots.
The recalled product
- Product
- ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X…
- 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 900-1832
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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