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 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
Enforcement
- Recall Number
- Z-1243-2019
- Event ID
- 82522
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Molnlycke Health Care, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 8, 2019
- Initiation Date
- March 26, 2019
- Classification Date
- April 30, 2019
- Termination Date
- June 2, 2021
- Address
- 5550 Peachtree Pkwy Ste 500, N/A, Norcross, GA, 30092-2555, United States
Description
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 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.
Intermittent heat seal failures on the outer pouch of some EZ Derm products.
a. Part Number: 131703-03, Lot Numbers: 18418740, 18489748, 18489749, 18489750, 18497584, 18515343, 18515344, 19010755, 19011801, 19024014, 19024015, 19024017, 19027570, 19034016, 19041030, 19054457; b. Part Number: 131704-03, Lot Numbers: 18489747, 19041029; c. Part Number: 131705-03, Lot Numbers: 18409561, 18411794, 18421375, 18421378, 18448600, 18457912, 18458926, 18460179, 18489746, 18497582, 18497583, 18505338, 18505339, 18505340, 19033438, 19033439; d. Part Number: 131710-03, Lot Numbers: 18409559, 18411793, 18421334, 18421377, 18435885, 18448598, 18453214, 18453297, 18453300, 18453303, 18505328, 18505329, 18505330; e. Part Number: 131711-03, Lot Number 18409562; f. Part Number: 131712-03, Lot Numbers: 18409557, 18411791, 18418739, 18421332, 18429844, 18435028, 18435029, 18448582, 18448596, 18458925, 18460132, 18460145, 18460174, 18460175, 18470176, 18489702, 18489703, 18489704, 18489745, 18497579, 18497580, 18497581, 18505332, 18505333, 18505334, 18515336, 18515337, 19024010, 19024011, 19024013, 19033435, 19034012; g. Part Number: 131713-03, Lot Numbers: 18411792, 18421333, 18421376, 18429855, 18435030, 18435031, 18435032, 18448584, 18448597, 18448599, 18453295, 18453298, 18453301, 18460133, 18460146, 18460177, 18470178; h. Part Number: 131714-03, Lot Numbers: 18409555, 18411790, 18418738, 18421331, 18435025, 18435026, 18448583, 18448595, 18460130, 18460134, 18460171, 18460172, 18470173, 18489699, 18489700, 18489701, 18497576, 18497577, 18497578, 18515341, 18515342, 19010584, 19024006, 19024007, 19024009, 19033234, 19033441, 19034008, 19041077, 19041080, 19054456; i. Part Number: 131715-03, Lot Numbers: 18435886, 18453296, 18453299, 19041079, 19041081
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.
1,332 units