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Completed

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

FDA Recall Z-2313-2021 · Posted None

Recalling FirmEpimed International
Recall StatusCompleted
Product CodeBSO
Date Initiated2017-12-28
Product Quantity140 units

Reason for Recall

Potential for stylet to protrude from the distal end of the catheter

Firm Action

On about 12/28/2017, Epimed mailed their recall notification letter titled, URGENT Medical Device RECALL, to customers. Those letters were followed up with a telephone call or email containing the letter on about 12/30/2017. The letter explained the issue and hazard and requested that if any potentially affected product remains in the accounts inventory, Epimed will offer to replace/credit the affected product. Each customer was asked to complete and return the RECALL RETURN RESPONSE FORM as soon as possible.

Root Cause

Process control

Distribution Pattern

Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981329FETH-R-KATHEpimed International, Inc. · 1998-08-26

Official Source

View FDA Recall →

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

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