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Open, Classified

injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge

FDA Recall Z-1478-2023 · Posted 2023-04-28

Recalling FirmLabories Medical Technologies
Recall StatusOpen, Classified
Product CodeFBK
Date Initiated2023-02-07
Product Quantity415,480 units

Reason for Recall

The packaging may be damaged, compromising the sterile barrier.

Firm Action

A customer letter dated February 7, 2023 was issued to impacted consignees. The letter asks consignees to examine their inventory for affected product lots and to complete a response card to the recalling firm. Return of impacted product will be coordinated with Laborie Medical Technologies.

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090830LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPLaborie Medical Technologies, Ltd. · 2009-07-21

Official Source

View FDA Recall →

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

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