Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504300, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way
FDA device recall Z-0389-2011 · posted 2010-11-15 · Terminated
Recall details
- Recalling firm
- Sorin Group USA, Inc.
- Reason for recall
- Defective product packaging may compromise product sterility.
- Action taken
- Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible. For further information, contact 1-800-650-2623.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 18
- Distribution
- Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
- Date initiated
- 2010-10-07
- Date posted
- 2010-11-15
- Date terminated
- 2010-12-17
- Location
- Arvada, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK (K881330) | Cobe Laboratories, Inc. | 1988-06-10 |