Recall Z-2112-2014— Wellspring Pharmaceutical Corporation

Name: FDA recall Z-2112-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-25

Class I · Terminated

Class I FDA medical device recall by Wellspring Pharmaceutical Corporation, initiated 2014-03-25, terminated 2014-09-08. It names one FDA 510(k) clearance: K123113. Product: IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.. Reason: Potential for microbial contamination of the product..

Recalling firm: Wellspring Pharmaceutical Corporation
Classification: Class I
Status: Terminated
Initiated: 2014-03-25
Terminated: 2014-09-08
Firm location: Sarasota, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K123113 — L.A.M. IMP WOUND GELGlycobiosciences, Inc.·cleared 2012-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.

Reason for recall

Potential for microbial contamination of the product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.