Z-1810-2019Class II
Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet
Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2019-04-23 / Terminated / root cause: manufacturing process
Arrow International Inc began a recall of Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2 on . FDA classified it as Class II and gives the reason as "Lidstock states the incorrect expiration date for the product". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1810-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Product
- Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2
- Product code
- LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Reason for recall
- Lidstock states the incorrect expiration date for the product
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Arrow International initiated recall by letter dated April 23,2019 described the problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Complete the enclosed Acknowledgement Form indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. Distributors requested to subrecall. Questions, contact your local sales representative or Customer Service at 1-866-396-2111.
- Quantity in commerce
- 279 units
- Distribution
- Nationwide Foreign:
- Product codes and lots
- Batch Code:23F18A0307, 23F18K0604
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1787-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1788-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1789-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1790-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1791-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1792-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1793-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1794-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1795-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1796-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1797-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1798-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1799-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1800-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1801-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1802-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1803-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1804-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1805-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1806-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1807-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1808-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1809-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1810-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1811-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1812-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1813-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1814-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1815-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1816-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1817-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1818-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1819-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1820-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1821-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1822-2019 | Class II | Terminated | Voluntary: Firm initiated |
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