Customed Recalls Laparoscopy Premium Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Laparoscopy Premium 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 (injury due to contamination or loss of sterility) for a medical device, but the source text does not report any actual illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Customed, Inc. is recalling seven lots of Laparoscopy Premium Packs, totaling 128 units. The recall involves specific catalog numbers and lot numbers identified in the agency's records. These medical device packs contain various surgical instruments and supplies, including trocars, drapes, and gauze, packaged in polyester/polyethylene breather bags with Tyvek double vents.
The recall was initiated because Customed determined that there is a possibility that the packaging integrity may be compromised on these specific lots. If the packaging is compromised, it could result in product contamination or a loss of the sterile condition, which poses a risk of injury to patients.
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. Users of these medical devices should stop using the affected lots and contact Customed, Inc. for further instructions or replacement.
The recalled product
- Product
- LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT 15" x 20" UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) DRAPE LASER CAMERA W/EL UF (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) (1) APPLIER CLIP 5MM (3) GOWN XLGE SMS IMPERV. REINFORCED (1
- 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)
- Product code 900-1803
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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