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Terminated

The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths

FDA Recall Z-0954-04 · Posted 2004-07-20

Recalling FirmMedtronic Xomed, Inc.
Recall StatusTerminated
Product CodeFED
Date Initiated2004-01-29
Date Terminated2012-05-03
Product Quantity7 boxes, 5 sheaths per box

Reason for Recall

The sheaths in question have shafts that are one inch longer than required for the endoscope specified on the label.

Firm Action

A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.

Root Cause

Other

Distribution Pattern

Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982594ENDO-SCRUB/ENDO-SCRUB 2Xomed, Inc. · 1998-08-27

Official Source

View FDA Recall →

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

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