BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
Becton Dickinson & Company began a recall of BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack on . FDA classified it as Class II and gives the reason as "Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2889-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Becton Dickinson & Co
- Product
- BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
- Product code
- FMI Needle, Hypodermic, Single Lumen
- Reason for recall
- Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.
- Root cause tag
- manufacturing process
- FDA root cause
- Equipment maintenance
- Action
- BD Sent a customer letter dated 28 July 2020. this letter requests customers to review their inventory for effected lots and Destroy all product subject to the recall. The letter requests customers to return the included response form and notify BD of any adverse events associated to this product.
- Quantity in commerce
- 125,200 units
- Distribution
- US and Canada
- Product codes and lots
- Catalog #: 305924 Lot #: 8289599 UDI #: 30382903059240
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2889-2020 | Class II | Terminated | Voluntary: Firm initiated |
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