Recall Z-1857-2012
Hartmann USA, Inc · initiated May 14, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
Codes / lots: Item # 416105 (Econolux): 101546391, 101646398, 101747392, 101850399, 101952309, 200106397
Reason for recall
Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products
FDA-determined cause: Material/Component Contamination
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.
Details
- Recall number
- Z-1857-2012
- Initiated
- May 14, 2012
- Posted by FDA
- June 22, 2012
- Terminated
- October 6, 2014
- Product code
- NAB – Gauze / Sponge,Nonresorbable For External Use
- Quantity
- 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.
- Recalling firm
- Hartmann USA, Inc, Rock Hill, SC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1858-2012 Class II | Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case…Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and… | 05/14/2012Terminated |