EasyPoint Needle may detach inside patient during use
Retractable Technologies is recalling EasyPoint Needles (25G x 5/8", REF: 82091) because the needle cannula may detach from the needle holder inside the patient.
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 is an FDA Class II recall of a medical device with a defect that presents a risk of harm (needle cannula detachment inside patient). No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Retractable Technologies, Inc. is recalling EasyPoint Needles (25G x 5/8", reference number 82091, lot K220402) used for injections. The recall is because the needle cannula may detach from the needle holder while the needle is in use inside the patient.
The recalled needles were distributed nationwide throughout the United States. Approximately 477,600 units are affected. These needles carry lot number K220402 with an expiration date of 03/28/2027.
If the needle cannula detaches inside a patient, the needle tip could remain in the patient's body. This poses a risk of injury to the patient. Healthcare providers and patients should discontinue use of these needles immediately. Contact Retractable Technologies, Inc. for instructions regarding disposal of the recalled needles or replacement with a safe alternative product.
The recalled product
- Product
- EasyPoint Needle, 25G x 5/8", REF: 82091
- Manufacturer
- Retractable Technologies, Inc.
- Affected units
- 477,600
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 (1)
- UDI-DI: 00613703820907. Lot: K220402. Expiration: 03/28/2027
Distribution
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