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Terminated

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

FDA Recall Z-1432-06 · Posted 2006-08-24

Recalling FirmConvaTec
Recall StatusTerminated
Product CodeLNO
Date Initiated2006-07-13
Date Terminated2007-01-18
Product Quantity3,857 units

Reason for Recall

Cartons labeled 1-1/4 inch size may contain units that are 1-1/2 inch size.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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