Z-1432-06
Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. by ConvaTec...
ConvaTec Limited / initiated 2006-07-13 / Terminated / root cause: labeling and UDI
ConvaTec began a recall of Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. by ConvaTec, Skillman, NJ on . The reason FDA records is "Cartons labeled 1-1/4 inch size may contain units that are 1-1/2 inch size". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1432-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- ConvaTec Limited
- Product
- Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. by ConvaTec, Skillman, NJ.
- Product code
- LNO
- Reason for recall
- Cartons labeled 1-1/4 inch size may contain units that are 1-1/2 inch size.
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- Notification to all direct customes (tier 1) with letter to tier 1 distributors for tier 2 customers was sent via first class mail on 7/13/06 or direct visit by ConvaTec Sales Reps.
- Quantity in commerce
- 3,857 units
- Distribution
- Nationwide
- Product codes and lots
- Lot #5H0436N. UPC Code: 30003-022766
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