injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25
Summary
The FDA issued a Class II for injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in lengt by Labories Medical Technologies. Reason: The packaging may be damaged, compromising the sterile barrier..
Details
Source
Device Recall
External ID
Z-1478-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
Product Description
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
Lot/Code Info: Model DIS199, UDI-DI (GTIN): 00627825000017 Lots: D198592, D211823, D19C094, D211825, D197765, D215573, D19B105, D214446, D19C097, D213099, D19C742, D214448, D201666, D213385, D202622, D216690, D203779, D217602, D204597, D21A632, D198638, D21B406, D204100, D219650, D201620, D221275, D207081, D218636, D205443, D21C155, D205441, D221088, D205445, D222083, D207623, D223087, D20A091, D224083, D20C092, D224386, D208579, D225586, D20C094, D225589, D20A092, D227088, D20B085, D226108, D211094, D228087 Model DIS201, UDI-DI (GTIN): 00627825000024 Lots: D19B109, D214447, D199716, D211094, D19B106, D214449, D19C789, D215574, D19C788, D216689, D19C098, D219083, D19C743, D217081, D201667, D218089, D203778, D21B407, D202623, D21B081, D204598, D21A082, D205444, D221277, D205440, D21C156, D203783, D221089, D205442, D221276, D204101, D222084, D203780, D224084, D207624, D221087, D207082, D222082, D208580, D223088, D205446, D226109, D20B086, D224387, D20A093, D227089, D20C095, D228088, D20C093, D226107, D211824, D228197, D211095, D229088, D211826, D22A099, D213100, D22A719, D213386, D229086
Quantity Affected: 415,480 units
Reason for Recall
The packaging may be damaged, compromising the sterile barrier.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-07
Company
Portsmouth, NH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Labories Medical Technologies) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Labories Medical Technologies have FDA actions?
This is the only FDA action we have on record for Labories Medical Technologies in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1478-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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