Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label shows the product is Man
FDA device recall Z-0081-2012 · posted 2011-10-24 · Terminated
Recall details
- Recalling firm
- Progressive Medical Inc
- Reason for recall
- The product may have a higher flow rate than specified resulting in over administration of drug solutions to the patients.
- Action taken
- The firm, Progressive Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated July 28, 2011 via email and regular mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue their use; remove the products from inventory and quarantine them; inform their customers to return unused products to Progressive; return the product, and complete and return the RECALL RETURN RESPONSE FORM via fax to 314-961-5786. Progressive customer service will contact the customers to coordinate the return of the goods in question. Should you have any questions, please call 800-969-6331 or email to dsullivan@progressivemedinc.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MEB
- Quantity affected
- 180 units
- Distribution
- Nationwide distribution: USA including states of: FL, KY, PA, VA and WY.
- Date initiated
- 2011-07-28
- Date posted
- 2011-10-24
- Date terminated
- 2011-12-19
- Location
- Saint Louis, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP (K081905) | Westmed, Inc. | 2008-07-15 |