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Recall Observatory FDA recall evidence

Device product

SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.

Z-0525-2018

October 26, 2017

Class II

Product summary

Firm
ConvaTec, Inc
Event
Event 78507
Status
Terminated
Classification
Class II
Quantity
47,630 units (4,763 market units, 10 per pack)
Official record key
device-enforcement:Z-0525-2018

Official wording

Reason: A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).

Code information: Lot 7H02242

Distribution pattern: Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled