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Terminated

PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15

FDA Recall Z-2800-2015 · Posted 2015-09-21

Recalling FirmZien Medical Technologies, Inc
Recall StatusTerminated
Product CodeGDX
Date Initiated2015-08-18
Date Terminated2015-12-09
Product Quantity28,284

Reason for Recall

Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.

Firm Action

All consignees have been notified via email with an attached copy of the recall letter. Telephone calls with be made to all customers and distributors that do not respond directly to email notification to ensure compliance to the recall.

Root Cause

Packaging process control

Distribution Pattern

Worldwide distribution to U.S. nationwide, Germany and England.

Official Source

View FDA Recall →

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

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