Recall Z-1798-2021 ยท MEG Syringe, Antistick
Smiths Medical ASD Inc.
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
| Date | Jun 10, 2021 (initiated May 17, 2021) |
| Status | Terminated |
| Reason | 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 | Process control |
| Action | 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. |
| Quantity | 1,432,200 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of UK, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063755 | PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE Smiths Medical Asd, Inc., Feb 27, 2007 |