Active Life One-Piece Closed-End Pouch

• 2 recalls, same reason

  • Terminated Z-1531-06 FDA Unclassified (pre-2012) ·initiated 31 Jul 2006 ·on shared 510(k) K840568
  • Terminated Z-1532-06 FDA Unclassified (pre-2012) ·initiated 31 Jul 2006 ·on shared 510(k) K840568

  Cartons may contain one or more units that are 1 1/2'' size rather than 1 3/4'' size as indicated on the label.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K840568 ↗

FDA Product Code

EXB

Device Class

Class I

Regulation

21 CFR Part 876.5900

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Duoderm(R) Adhesive Compression Bandage, Modified

  Class I

  FDA 510(k) K912550 Active Cleared 14 Aug 1991

• Duoderm Dressings, Cgf Dressings, Paste Full Thick

  Unclassified

  FDA 510(k) K904852 Active Cleared 25 Jan 1991

• Stomahesive Skin Barrier Sterile

  Class I

  FDA 510(k) K851840 Active Cleared 24 Jun 1985

• Allkare Barrier Wipe

  Class I

  FDA 510(k) K925004 Active Cleared 12 Jan 1994

• Duoderm* Extra Thin Flexible Hydrocolloid Dressing

  Class I

  FDA 510(k) K891696 Active Cleared 4 May 1989

• Nonwoven Pad

  Class I

  FDA 510(k) K980720 Active Cleared 15 Apr 1998

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