Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleans

FDA device recall Z-1857-2012 · posted 2012-06-22 · Terminated

Recall details

Recalling firm

Hartmann USA, Inc

Reason for recall

Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products

Action taken

The firm, HARTMANN USA, sent an "URGENT: RECALL NOTICE" dated May 14, 2012 to its Consignees/Customers. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, block further shipments of affected items and retrieve additional affected stock from their customers; to confirm initial receipt of the notice by emailing recall@harmanninfo.com; complete and return the Affected Products and Stock Levels form via fax to: HARTMANN USA customer service at (1-803-325-7606); contact customer service to obtain a Returned Goods Authorization; and take adequate measures to ensure this notice is distributed appropriately. If you have any further questions or issues related to this recall, please contact HARTMANN USA customer service or your sales representative at 1-800-243-2294 or email: recall@hartmanninfo.com.

Root cause

Material/Component Contamination

Status

Terminated

Product code

NAB

Quantity affected

Lot 101546391 - 200 cs; Lot 101646398 - 200 cs; 101747392 - 120 cs; Lot 101850399 - 160 cs; Lot 101952390 - 240 cs; Lot 200106397 - 200 cs

Distribution

Nationwide distribution: USA including states of: AZ, CA, FL, GA, KY, MO, MS, NC, PA, SC, TN, TX, and VA.

Date initiated

2012-05-14

Date posted

2012-06-22

Date terminated

2014-10-06

Location

Rock Hill, SC