Customed Recalls Knee Arthroscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Knee Arthroscopy Packs 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 (injury due to contamination or loss of sterility) in a medical device where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity rating.
Plain-English summary
Customed, Inc. has initiated a recall of Knee Arthroscopy Packs, code 900-2718. The recall involves 3 lots totaling 84 units. The affected lots are identified by the codes 113026299, 113068033, and 113078728.
The recall was issued because Customed determined there is a possibility that the packaging integrity of these surgical packs may be compromised. If the packaging is not intact, it could result in product contamination or a loss of the sterile 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. Healthcare facilities and consumers should check their inventory for these specific lot codes and discontinue use if found.
The recalled product
- Product
- Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERM
- 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)
- Code 900-2718: 3 lots 113026299 113068033 113078728
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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