Customed Recalls Hip and Knee Replacement Packs Due to Sterility Concerns
Customed, Inc. is recalling Hip & Knee replacement packs (900-2614) 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility…"
Plain-English summary
Customed, Inc. is recalling one lot (30 packed units) of Hip & Knee replacement packs, product code 900-2614, lot number 140312137. The recall was initiated because the company determined there is a possibility that packaging integrity may be compromised on different catalog numbers across multiple lots.
The compromised packaging could result in an injury to the patient due to product contamination or loss of sterility condition. The affected products are EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bags with Tyvek double vents.
The distribution pattern for this recall includes worldwide distribution, specifically the United States (nationwide) in the state of Florida including Puerto Rico (USA) and the USVI (St John), as well as the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REINFORCED UF (5) TOWELS ABSORBENT 15" X 20" UF (2) DRAPE SHEET 70" X 100"…
- 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 900-2614
- 1 lot: 140312137
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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