—#187480

Product

JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1

FDA product code: MEG — Syringe, Antistick
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063755
Affected lot / code info: a) REF 4428-1, Lot Numbers: 4046543 and 4062235 b) REF 4429-1, Lot Numbers: 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238, 4062242, 4014096

Why it was recalled

Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated the recall on May 17, 2021 by email. The firm is seeking the removal of the product down to the consumer level. For assistance ease contact Novasyte using the Email: smithsmedical-Jelco2021@novasyte.com The firm later realized they failed to include lot #40140906 for model #4429-1 and issued a second letter which was dated 5/27/2021 to customers involved in the first notification where this lot was excluded in the letter, as well as to new consignees who received the affected lot.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of UK, Spain.

Timeline

Recall initiated: 2021-05-17
Posted by FDA: 2021-06-10
Terminated: 2023-10-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187480. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.