Prytime Medical REBOA Catheter Introducer Kit Recalled for Incorrect Needle Size
Prytime Medical Devices is recalling REBOA Catheter Introducer Kits because they may contain a 21G needle instead of the correct 18G needle, which could cause procedure delays or injury.
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: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Prytime Medical Devices, Inc. is recalling the PRYTIME MEDICAL REBOA Catheter Introducer Kit (REF: KT1835C). The recall is due to a potential manufacturing error where the kit may contain a 21G access needle instead of the correct 18G needle.
If the incorrect 21G needle is used to gain vascular access, the guidewire included in the kit will not pass through the needle. This failure prevents the insertion of the introducer sheath, which could cause a delay in the procedure or result in injury to the patient.
The affected product was distributed nationwide in the United States, including in states such as New Jersey, New York, California, Texas, and others. No specific lot numbers or dates are provided in the source text. Healthcare providers and consumers should check their inventory for this specific kit and contact Prytime Medical Devices for instructions on how to return the product.
The recalled product
- Product
- PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5…
- Manufacturer
- Prytime Medical Devices, Inc.
- Category
- Medical Device — Catheter
- Hazard
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)
- Lot # MFG 3590
Distribution
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