Norcross, GA, United States
Molnlycke Health Care, Inc recalls
2 recalls recorded since 2018, most recently on 26 March 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 March 2019
- Terminated
- 2 June 2021
- Reason
- Intermittent heat seal failures on the outer pouch of some EZ Derm products.
- Distribution
- Worldwide Distribution - US Nationwide distribution to AL, AZ, CA, CO, DC, FL, GA, IA, IL, KS, LA, MA, MD, MN, MO, NC, NE, NJ, OK, PA, RI, TN, TX, VA, WA, WI. International distribution to Chile, Jamaica.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1243-2019
- EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2
Terminated Class II Medical devices
- Recall started
- 26 July 2017
- Terminated
- 6 April 2021
- Reason
- Products may not meet specifications due to possible presence of metal shavings.
- Distribution
- Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0417-2018, Z-0416-2018
- 9x15" Medium Utility Positioner with Cover
- 7x10" Small Utility Positioner with Cover
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.