Customed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 74 units of Shoulder 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 metadata explicitly identifies the agency classification as Class I. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Customed, Inc. is recalling 74 units of Shoulder Arthroscopy Packs, code 900-2719, due to a potential compromise in packaging integrity. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents. The recall involves three specific lots: 113047020, 113068032, and 113078729.
The company determined that the compromised packaging could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
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. Healthcare facilities and consumers who have these specific lots should stop using the products and contact Customed, Inc. for instructions on return or replacement.
The recalled product
- Product
- Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G…
- 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 900-2719: 3 lots 113047020 113068032 113078729
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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