Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Z

FDA device recall Z-2133-2011 · posted 2011-05-03 · Terminated

Recall details

Recalling firm

Apogee Medical, Inc

Reason for recall

Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica.

Action taken

The firm, Apogee Medical LLC, sent an "Urgent Medical Device Recall" letter dated March 23, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review their inventory; complete and return the enclosed Product Recall Response Form as soon as possible via fax to (919) 570-9611, mail to: Apogee Medical LLC, Youngsville Commerce Center, 90 Weathers Street, Youngsville, MC 27596, or e-mail to: dpeper@apogeemed.com; cease further distribution and return any product that is the subject of this recall to Apogee Medical LLC. All returned product must be labeled with a returned goods authorization label that has been provided with the letter. Apogee will replace returned product upon receipt of the Product Recall Response Form and identified product. In addition, if the customer distributed the product, they are to identify their customer(s) and notify them at once of this product recall. The notification should include a copy of the this recall notification letter and should instruct the customer to return the recalled product so that it can be returned to Apogee. Should you have any questions regarding this notification, please call the Manager Regulatory Affairs/Quality Assurance at (919) 435-5409.

Root cause

Other

Status

Terminated

Product code

OHR

Quantity affected

5,503,430 units

Distribution

Nationwide distribution: USA including states of: AL, AZ, CA, FL, GA, IL, IN, KS, LA, MA, MO, NJ, NY, OH, OK, TN, TX, VA and WA.

Date initiated

2011-03-24

Date posted

2011-05-03

Date terminated

2012-02-28

Location

Youngsville, NC