Customed Recalls Lithotomy Pack III Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling Lithotomy Pack III surgical 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 product (loss of sterility/contamination) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Customed, Inc. is recalling Lithotomy Pack III (code 900-2487) surgical packs. The recall involves 300 packed units manufactured under the firm's control, with zero units distributed. The product is an EO sterilized surgical convenient pack packaged into a polyester/polyethylene breather bag with Tyvek double vents.
The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on different catalog numbers and multiple lots. This defect could result in an injury to the patient due to product contamination or loss of sterility condition.
The affected products were distributed worldwide, including the United States (nationwide, specifically Florida, Puerto Rico, and USVI St. John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. The specific lot number identified is 113078525. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 20" (1) GOWN LARGE STANDARD SMS VELCRO NECK (2) LEGGINS WITH 7" CUFF 30" X 42" (1) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" (1) DRAPE UTILITY WITH TAPE (1) COV
- 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)
- code 900-2487
- 1 lot: 113078525
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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