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U.S. Department of Health and Human Services

Class 2 Device Recall Lysus

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  Class 2 Device Recall Lysus see related information
Date Initiated by Firm October 12, 2006
Date Posted November 16, 2006
Recall Status1 Terminated 3 on November 20, 2006
Recall Number Z-0195-2007
Recall Event ID 36517
Product Classification infusion stand - Product Code FDX
Product Lysus Transport Stand (infusion stand), part number 4896-003
Code Information 060113010-001, 060113010-002, 060113010-003, 060113010-004, 060113010-005, 060113010-006,  060113010-007, 060113010-008, 060113010-009,  060113010-010, 060113010-011, 060113010-012, 060113010-013, 060113010-014, 060113010-015,  060324025-001, 060324025-002  The additional carts do not contain any type of serial number.
Recalling Firm/
Manufacturer		 Ekos Corp
22030 - 20th Ave SE, Ste 101
Bothell WA 98021
For Additional Information Contact Jocelyn Kersten
425-415-3132
Manufacturer Reason
for Recall		 Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard.
FDA Determined
Cause 2		 Other
Action The firm''s representatives will visit the consignees, apply the caution label and provide a letter, dated October 2, 2006, to the consignee. The letter states that the representative applied the caution label to the cart and reminds consignees if the UPS is removed and the cart is loaded with pumps and bags there is a potential for the cart to tip.
Quantity in Commerce 84 carts
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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