FDA Recalls injeTAK Adjustable Tip Needles for Damaged Packaging
Labories Medical Technologies is recalling injeTAK Adjustable Tip Needles because packaging damage may compromise the sterile barrier, creating a risk of contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves risk of harm due to sterile barrier compromise with no reported illnesses or injuries, fitting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Labories Medical Technologies is recalling 415,480 units of injeTAK Adjustable Tip Needles (Model DIS199 and DIS201). These are 25-gauge stainless-steel needles with a 6 French needle sheath diameter and 35-50 cm length. The affected needles have been distributed worldwide.
The packaging for these needles may be damaged, compromising the sterile barrier that protects the needles from contamination. A compromised sterile barrier increases the risk of bacterial or fungal contamination that could cause infection when the needles are used for injection.
Healthcare providers and individuals with these needles should stop using them immediately. Users should inspect packaging for damage and contact Labories Medical Technologies with lot number information for instructions on replacement or return.
The recalled product
- Product
- injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
- Manufacturer
- Labories Medical Technologies
- Affected units
- 415,480
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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