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Terminated

3M Ioban 2 Antimicrobial Incise Drapes, Model 6648EZ

FDA Recall Z-0838-03 · Posted 2003-05-16

Recalling Firm3m Health Care
Recall StatusTerminated
Product CodeKKX
Date Initiated2003-04-07
Date Terminated2004-07-02
Product Quantity3679 drapes

Reason for Recall

The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.

Firm Action

3M sent Cardinal Health a letter dated April 7, 2003 to provide to their customers. The letter instructed the customers to remove Ioban 2 drapes contained in Cardinal Health packs and use a separately supplied equivalent drape.

Root Cause

Other

Distribution Pattern

Procedure packs containing the drapes were shipped nationwide in United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K8015503M GERMICIDAL SURGICAL INCISE DRAPE3M Company · 1981-09-17

Official Source

View FDA Recall →

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

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