Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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