Z-1252-2021Class II
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle...
Medtronic, Inc. / initiated 2021-02-09 / Terminated / root cause: manufacturing process
Cardinal Health 200, LLC began a recall of Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids... on . FDA classified it as Class II and gives the reason as "Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1252-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- Product
- Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881833558
- Product code
- FMI Needle, Hypodermic, Single Lumen
- Reason for recall
- Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
- Root cause tag
- manufacturing process
- FDA root cause
- Equipment maintenance
- Action
- Cardinal Health issued Urgent Medical Device Recall letter on 2/9/21via overnight mail. Letter states reason for recall, health risk and action to take: 1. INSPECT your inventory for the affected product code and lot number (see Attachment A for examples). 2. SEGREGATE and QUARANTINE all on-hand affected product. 3. PLEASE RETURN the enclosed acknowledgment form via facsimile (614-652-9648) or email ([email protected]) and indicate the product code, lot and quantity of product youve quarantined. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-54401. 6. Customers that did not receive product directly from Cardinal Health should return product through the location where they purchased it. Contact Cardinal Health at 800-292-9332.
- Quantity in commerce
- 6800 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.
- Product codes and lots
- Lot Code: 028610, 028611
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1250-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1251-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1252-2021 | Class II | Terminated | Voluntary: Firm initiated |
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