Smiths Medical ASD Inc. Recall 87945
Description: 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
Smiths Medical ASD Inc. Recall 87945 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1798-2021 |
| Event ID | 87945 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of UK, Spain. |
| Quantity | 1,432,200 units |
| Recall 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. |
| Device Classification | 20210616 |
| Device 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 |
| Center Classification Date | 20210610 |
| Recall Initiation Date | 20210517 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | |
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