Gambro Recalls Prisma M 100 PRE Sets Due to Connector Breakage
Gambro Renal Products is recalling Prisma M 100 PRE sets because connector breakages can cause leakage of liquid or blood.
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 is classified as FDA Class II and involves a risk of harm (leakage of blood/liquid) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Gambro Renal Products, Incorporated is recalling Prisma M 100 PRE sets (Product number 103657). The affected units are packaged in plastic pouches, with four pouches per carton box. The recall covers batch numbers 12A0302G to 14B2102 with expiry dates ranging from 01/2014 to 02/2016.
The field action was initiated due to breakages of connectors on the Prisma and Prismaflex sets. These breakages can result in the leakage of liquid or blood. The agency has classified this as a Class II recall.
The affected product was distributed worldwide. A total of 401,451 units are involved in this recall. Users should stop using the affected sets and contact the manufacturer for further instructions.
The recalled product
- Product
- Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Manufacturer
- Gambro Renal Products, Incorporated
- Affected units
- 401,451
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Gambro Renal Products, Incorporated 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 15 products in this recall →Related recalls
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