Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
FDA device recall Z-0035-2011 · posted 2010-10-20 · Terminated
Recall details
- Recalling firm
- Excelsior Medical Corp
- Reason for recall
- There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility
- Action taken
- Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 2, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue using syringes from the listed lots and return the attached Customer Reply Form via fax (866) 688-3185 as confirmation that notification had been received and that proper arrangements can be made to have the product returned to the firm. The customers were also instructed to inform their customers, if they have resold products, of the recall and instruct them to return the form, and verify that they have returned all unused syringes from any of the listed lots . NOTE: The customers were informed that they may alternatively have the products destroyed and certified to Excelsior that they have done so. They must include a copy of the certificate of destruction with the attached Customer Reply Form via fax. - Excelsior issued a press release on October 14, 2010. The press release advised consumers of the recall and requested that use of the product be immediately discontinued and returned to the point of purchase. Should you have any questions regarding the recalled product, please contact Excelsior Medical Customer Service at (800) 487-4276 or if you prefer by fax (866) 688-3185. You may also contact us at recall10@excelsiormedical.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 13,734,640
- Distribution
- Worldwide distribution: USA and countries including Canada and Brazil.
- Date initiated
- 2010-09-02
- Date posted
- 2010-10-20
- Date terminated
- 2012-08-23
- Location
- Neptune, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE (K090882) | Hospira, Inc. | 2010-04-23 |
| EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) (K962938) | Excelsior Medical Corp. | 1996-10-25 |