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Terminated

Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations

FDA Recall Z-2133-2011 · Posted 2011-05-03

Recalling FirmApogee Medical, Inc
Recall StatusTerminated
Product CodeOHR
Date Initiated2011-03-24
Date Terminated2012-02-28
Product Quantity5,503,430 units

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.

Firm Action

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: [email protected]; 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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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