Atlas FDA

Active Life Non-Convex Drainable Stomahesive pouch-1 1/4' (32 mm) Product No: 022766 Manf. by ConvaTec, Skillman, NJ.

FDA device recall Z-1432-06 · posted 2006-08-24 · Terminated

Recall details

Recalling firm
ConvaTec
Reason for recall
Cartons labeled 1-1/4 inch size may contain units that are 1-1/2 inch size.
Action taken
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.
Root cause
Other
Status
Terminated
Product code
LNO
Quantity affected
3,857 units
Distribution
Nationwide
Date initiated
2006-07-13
Date posted
2006-08-24
Date terminated
2007-01-18
Location
Skillman, NJ

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
ACTIVE LIFE (K833625)Convatec, A Division of E.R. Squibb & Sons1983-11-28