Recall Z-1798-2021
Smiths Medical ASD Inc. · initiated May 17, 2021
Class I – dangerous or defective products that could cause serious health problems or death
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
Codes / lots: 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
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1798-2021
- Initiated
- May 17, 2021
- Posted by FDA
- June 10, 2021
- Terminated
- October 11, 2023
- Product code
- MEG – Syringe, Antistick
- Quantity
- 1,432,200 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UK, Spain.
- Recalling firm
- Smiths Medical ASD Inc., Minneapolis, MN