Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 114 units of Shoulder Packs (Code 900-2616) because packaging integrity may be compromised, posing a risk of 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.
Plain-English summary
Customed, Inc. is recalling 114 units of Shoulder Packs, Code 900-2616, across four specific lots. The affected lots are identified by the codes 112083077, 113109907, 131110339, and 140312139. These surgical packs contain various items, including suction tubes, syringes, drapes, sponges, gowns, and table covers, and are EO sterilized and packaged in polyester/polyethylene breather bags with Tyvek double vents.
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 the patient.
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. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF…
- 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)
- 900-2616
- 4 lots: 112083077 113109907 131110339 140312139
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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