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FDA device recall Z-1866-2011 · posted 2011-04-01 · Terminated

Recall details

Recalling firm

Hartmann USA, Inc

Reason for recall

Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. Consignees were notified by letter on/about 02/11/2011. They were advised to examine their inventory and not to use any of the affected product and to return it to Paul Hartmann. A response form was included to be completed and returned to Paul Hartmann. They were further instructed to pass the no

Action taken

Hartmann USA, Inc. sent letter to the Consignees on 2/11/11. They were advised to examine their inventory and not to use any of the affected product and to return it to Hartmann USA, Inc. A response form was included to be completed and returned to Hartmann USA, Inc. They were further instructed to pass the notice on to their consignees if distributed. For questions, call (803) 325-7600.

Root cause

Other

Status

Terminated

Product code

MGP

Quantity affected

100 boxes (10 x 12.5 cm per box)

Distribution

Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.

Date initiated

2011-02-11

Date posted

2011-04-01

Date terminated

2011-08-12

Location

Rock Hill, SC