Z-2197-2014Class II
Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products / initiated 2014-07-18 / Terminated / root cause: design
Gambro Renal Products, Incorporated began a recall of Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box on . FDA classified it as Class II and gives the reason as "Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2197-2014
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Gambro Renal Products
- Product
- Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Product code
- KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Reason for recall
- Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return.
- Quantity in commerce
- 401,451
- Distribution
- Worldwide Distribution.
- Product codes and lots
- Prisma M 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2193-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2194-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2195-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2196-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2197-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2198-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2199-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2200-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2201-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2202-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2203-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2204-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2205-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2206-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2207-2014 | Class II | Terminated | Voluntary: Firm initiated |
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