Procedure Products Recalls Ultra Modified Seldinger Needles Due to Insertion Difficulty
Procedure Products, Inc. is recalling 1,100 non-sterile Seldinger needles because a medical professional reported difficulty inserting a guide wire.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a complaint regarding difficulty inserting a guide wire but does not report any injuries, illnesses, or hospitalizations. Per the rubric, a Class II recall without reported adverse health consequences or hospitalizations falls under the Moderate category.
Plain-English summary
Procedure Products, Inc. is recalling 1,100 pieces of U-SDN 2 Part Ultra Modified Seldinger Needles, model NS/37-0387. These needles are non-sterile, sold in bulk, and intended for further processing. They are packaged in zipper-bags of 300 pieces and shipped in corrugated cardboard boxes. The needles consist of a stainless steel cannula with a molded plastic hub and are intended to be placed over a guidewire to enlarge the opening in a vessel for percutaneous catheterization.
The recall was initiated after the firm received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle. The affected product is identified as Lot 9184-A. The needles were distributed in the states of Montana and New York.
No specific instructions for consumers are provided in the source text, as the product was sold in bulk for further processing. Medical professionals and facilities that may have received this product should contact the recalling firm for further instructions.
The recalled product
- Product
- U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a…
- Manufacturer
- Procedure Products, Inc.
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 1,100
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 9184-A
Distribution
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