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Terminated

Infant reusable blood pressure cuffs, one tube, male slip luer connector, P/N 2930 , manufactured for Welch Allyn Protocol, Inc. and labeled in part: '***Reusable Blood Pressure Cuffs Infant 50 Cuffs REF 008-0625-00 PROTOCOL SYSTEMS, INC. Beaverton, OR 97008-7107 USA Assembled in Mexico***.'

FDA Recall Z-1237-03 · Posted 2003-10-15

Recalling FirmGE Medical Systems Information Technologies
Recall StatusTerminated
Date Initiated2001-03-07
Date Terminated2008-04-15
Product Quantity100 cuffs

Reason for Recall

Wrong connector attached to blood pressure cuff.

Firm Action

The recalling firm telephoned the one account involved on 3/7/2001 and also mailed a Recall Notification letter to the firm on 3/7/2001 requesting return of the product.

Root Cause

Other

Distribution Pattern

Product was distributed to one distributor in Oregon.

Official Source

View FDA Recall →

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

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