| | Class 1 Recall
Excelsior Disposable Syringe W/Normal Saline |  |
| Date Posted |
October 20, 2010 |
| Recall Number |
Z-0035-2011 |
| Product |
Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride)
General hospital use |
| Code Information |
Product codesL E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000 and S5.
Lot code/ Expiration date
26-011-DS 10/1/2010
28-010-DS 1/1/2011
32-010-DS 10/1/2010
79-017-9D 7/1/2011
84-038-9D 12/1/2011
86-020-9D 2/1/2012
83-034-9D 11/1/2011
88-120-9D 4/1/2012
32-024-DS 10/1/2010
23-029-DS 8/1/2010
27-034-DS 12/1/2010
29-011-DS 2/1/2011
79-018-9D 7/1/2011
79-021-9D 7/1/2011
81-070-9D 9/1/2011
88-076-9D 4/1/2012
32-011-DS 10/1/2010
21-029-DS 7/1/2010
30-023-DS 10/1/2010
67-023-9D 7/1/2010
67-034-9D 7/1/2010
68-050-9D 8/1/2010
68-052-9D 8/1/2010
68-053-9D 8/1/2010
68-054-9D 8/1/2010
69-041-9D 9/1/2010
70-019-9D 10/1/2010
70-021-9D 10/1/2010
70-025-9D 10/1/2010
70-030-9D 10/1/2010
70-042-9D 10/1/2010
71-005-9D 11/1/2010
71-008-9D 11/1/2010
72-007-9D 12/1/2010
72-022-9D 12/1/2010
72-023-9D 12/1/2010
72-024-9D 12/1/2010
73-010-9D 1/1/2011
73-014-9D 1/1/2011
73-017-9D 1/1/2011
73-019-9D 1/1/2011
73-024-9D 1/1/2011
73-027-9D 1/1/2011
74-036-9D 2/1/2011
74-039-9D 2/1/2011
74-046-9D 2/1/2011
74-053-9D 2/1/2011
74-054-9D 2/1/2011
74-056-9D 2/1/2011
74-059-9D 2/1/2011
75-001-9D 3/1/2011
75-004-9D 3/1/2011
75-017-9D 3/1/2011
75-051-9D 3/1/2011
75-052-9D 3/1/2011
75-056-9D 3/1/2011
75-057-9D 3/1/2011
76-003-9D 4/1/2011
76-006-9D 4/1/2011
76-010-9D 4/1/2011
76-031-9D 4/1/2011
77-063-9D 5/1/2011
77-067-9D 5/1/2011
83-032-9D 11/1/2011
83-033-9D 11/1/2011
83-040-9D 11/1/2011
83-047-9D 11/1/2011
83-048-9D 11/1/2011
84-039-9D 11/1/2011
84-040-9D 12/1/2011
86-021-9D 2/1/2012
88-121-9D 4/1/2012
88-133-9D 4/1/2012
89-118-9D 5/1/2012
89-136-9D 5/1/2012
67-001-9D 7/1/2010
67-004-9D 7/1/2010
67-021-9D 7/1/2010
|
Recalling Firm/
Manufacturer |
Excelsior Medical Corp
1933 Heck Ave
Neptune, New Jersey 07753 |
| For Additional Information Contact |
John Linfante
732-776-7525
|
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 |
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. |
| Quantity in Commerce |
13,734,640 |
| Distribution |
Worldwide distribution: USA and countries including Canada and Brazil. |
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