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Terminated

Kendall Kerlix A.M.D. Antimicrobial Large Roll, Sterile 6 ply-4.5 in x 4.1 yd Product Number: 3331

FDA Recall Z-0380-04 · Posted 2004-07-20

Recalling FirmKendall Healthcare Products Co
Recall StatusTerminated
Product CodeNAD
Date Initiated2004-01-08
Date Terminated2012-05-15
Product Quantity1 case

Reason for Recall

Sterility compromised due to lack of package seal integrity

Firm Action

Kendall issued Recall letters by US Mail to all customers on January 8, 2004, requesting product be returne and dealer customers be notified.

Root Cause

Other

Distribution Pattern

AL, AZ, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO,NC NE, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGThe Kendall Company, L.P. · 2000-01-31

Official Source

View FDA Recall →

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

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