Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO, Rx Only, Gyrus ACMI, Inc. 13

FDA device recall Z-2383-2011 · posted 2011-05-26 · Terminated

Recall details

Recalling firm

Gyrus Acmi, Incorporated

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

KNY

Quantity affected

145

Distribution

Nationwide distribution: USA including states of: CA, GA, HI, IN, KY, MT, NY, NC, PA, TX, UT, and WA.

Date initiated

2011-04-15

Date posted

2011-05-26

Date terminated

2012-08-23

Location

Southborough, MA