Gi Supply Recalls Large Volume Paracentesis Kits Due to Missing Clamp
Gi Supply is recalling Large Volume Paracentesis Kits because the pinch clamp on the RP Bag may be missing, posing a splash hazard to users.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 where injury has not yet been reported, specifically a splash hazard from missing components.
Plain-English summary
Gi Supply is recalling 390 Large Volume Paracentesis Kits (Catalog #: GIS-28, Lot #: 61442434, Expiration Date: 2018/04). The recall was initiated after customers reported that the pinch clamp on the RP Bag was missing from the kits.
The missing clamp creates a safety hazard because ascitic fluid from the abdominal cavity may splash the user if the bag is not clamped prior to removal. The kits are packaged in a thermaformed tray and packed sterile in a Tyvek bag.
The affected kits were distributed in the District of Columbia and the states of California, Florida, Iowa, Kentucky, Massachusetts, Missouri, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, and Tennessee. Users should stop using the affected kits and contact Gi Supply for further instructions.
The recalled product
- Product
- Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04
- Manufacturer
- Gi Supply
- Category
- Medical Device — Surgical Kits
- Affected units
- 390
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)
- Lot #: 61442434 Expiration Date: 2018/04
Distribution
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