Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical convenient 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 (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination or loss of sterility.
Plain-English summary
Customed, Inc. is recalling EO sterilized surgical convenient packs, specifically the BASIC PACK containing table covers, towels, gauze sponges, and drapes. The recall involves one lot (109010222) with 40 units, distributed nationwide in the United States, including Puerto Rico, USVI, and several international countries.
The recall was initiated because Customed determined that packaging integrity may be compromised on different catalog numbers. This defect could result in product contamination or a loss of the sterile condition, posing a risk of injury to patients.
Consumers and healthcare facilities should stop using the affected products and contact Customed, Inc. for further instructions or a replacement.
The recalled product
- Product
- BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into polyester/polyethyle
- 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 900-1880
- 1 lots: 109010222
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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