Agency classClass IIIOur severity:Low FDA (Devices)·Z-1829-2017·Announced 2017-04-26

Teleflex Medical Recalls Arrow EZ-IO Needle Sets Due to Missing Packaging Labels

Teleflex Medical is recalling Arrow EZ-IO Needle Sets because some individual unit pouches are missing lot numbers and expiration dates.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, and the hazard is limited to missing lot numbers and expiration dates on packaging, which constitutes a documentation/packaging issue rather than a direct safety hazard.

Plain-English summary

Teleflex Medical is recalling 4,760 units of Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. The recall was initiated because some of the individual unit packaging (pouches) may be missing the lot number and expiration date.

The affected products were distributed to facilities in numerous U.S. states, including Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming. The products were also distributed to Canada and Costa Rica.

This is a Class III recall, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences. The missing information on the packaging is a documentation and labeling issue. Healthcare facilities should check their inventory for these specific needle sets and contact Teleflex Medical for further instructions.

The recalled product

Product: Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Manufacturer: Teleflex Medical
Category: Medical Device — Needles and Cannulas
Hazard: mis-labeling
Affected units: 4,760

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)

4799431

Distribution

Distributed in 48 states:

Same manufacturer · Teleflex Medical

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