Recall Z-1478-2023— Labories Medical Technologies

Name: FDA recall Z-1478-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-07

Class II · Ongoing

Class II FDA medical device recall by Labories Medical Technologies, initiated 2023-02-07. It names one FDA 510(k) clearance: K090830. Product: injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge. Reason: The packaging may be damaged, compromising the sterile barrier..

Recalling firm: Labories Medical Technologies
Classification: Class II
Status: Ongoing
Initiated: 2023-02-07
Firm location: Portsmouth, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K090830 — LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIPLaborie Medical Technologies, Ltd.·cleared 2009-07-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The packaging may be damaged, compromising the sterile barrier.

Data sourced from openFDA. This site is unofficial and independent of the FDA.