Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures.
Recall
- Recall Number
- Z-2383-2011
- Event Number
- 58650
- Firm
- Gyrus Acmi, Incorporated
- FEI Number
- 3003790304
- Product Code
- KNY
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 15, 2011
- Posted
- May 26, 2011
- Terminated
- August 23, 2012
- Address
- 136 Turnpike Road, Southborough, MA, 01772-2118
Description
Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 136 Turnpike Road,Southborough, MA 01772-2104 USA Ureteral guidewires are used to establish access in the urinary system for the passage of urological devices. An introducer is first used to establish entry to various portions of the urinary tract (urethra, bladder, ureter), then a guidewire is threaded through the introducer. Following placement of the guidewire, various urological devices can be introduced into the targeted portion of the urinary tract for various therapeutic and diagnostic procedures.
Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a result of a manufacturing error in the production this lot of guidewires, some units of product were loaded in the dispenser backwards. In such cases, the stiff end of the guidewire would be dispensed from the product first and, if undetected, could be inserted into the patient. Depending on the specific clinical circumstances of the patient, this could potentially cause perforation of the ureter and surrounding anatomy. Therefore Gyrus ACMI has chosen, out of an abundance of caution, to conduct a voluntary recall of this lot of product.
The firm, Olympus ACMI, sent an "Urgent: Medical Device Recall" letter dated April 15, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) Inspect their stock to confirm if any of the affected lot of products remains in their possession 2)Immediately cease any further use of the affected product, remove, quarantine and return it. 3) Call their Gyrus ACMI customer service representative at 1-888-542-7266 to obtain a Returned Goods Authorization 4) Return the product to: Attn: PTFE Guidewire Recall RGA#_________Gyrus ACMI LP, 6845 Wedgwood Court, Maple Grove, MN 55311 5) Complete and return the RECALL REPLY FORM via fax, even if they are returning no product, to: Regulator Affairs (508) 804-2624. The letter states that the customer will receive repeat mailings until they have faxed in the form. Additionally, If they have further distributed the product they are requested to identify and notify their customers at once. If you have any questions, please do not hesitate to contact customer service at 1-888-524-7266.
Nationwide distribution: USA including states of: CA, GA, HI, IN, KY, MT, NY, NC, PA, TX, UT, and WA.
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