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U.S. Department of Health and Human Services

Class 1 Device Recall Excelsior Disposable Syringe W/Normal Saline

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 Class 1 Recall
Excelsior Disposable Syringe W/Normal Saline
see related information
Date Posted October 20, 2010
Recall Status1 Terminated on August 23, 2012
Recall Number Z-0035-2011
Recall Event ID 56685
Premarket Notification
510(K) Number
K090882 
Product Classification Saline, Vascular Access Flush - Product Code NGT
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
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Device Design
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NGT and Original Applicant = HOSPIRA, INC.
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