Molnlycke Recalls EZ Derm Porcine Xenograft Due to Heat Seal Failures
Molnlycke Health Care is recalling 1,332 units of EZ Derm Porcine Xenograft due to intermittent heat seal failures on the outer pouch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level where the hazard is unlikely to cause serious adverse health consequences but may cause temporary or medically reversible harm.
Plain-English summary
Molnlycke Health Care, Inc. is recalling 1,332 units of EZ Derm Porcine Xenograft. The recall is due to intermittent heat seal failures on the outer pouch of some products. The affected products include various sizes and perforation types of the EZ Derm line, identified by specific part numbers and lot numbers.
EZ Derm is a porcine-derived xenograft used for partial thickness skin loss injuries, burns, donor sites, and chronic vascular ulcers. The product is distributed nationwide in the United States and internationally to Chile and Jamaica. The specific distribution includes 27 US states and the District of Columbia.
Consumers and healthcare providers should stop using the affected products and contact Molnlycke Health Care for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- 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.…
- Manufacturer
- Molnlycke Health Care, Inc
- Category
- Medical Device — Wound Care
- Affected units
- 1,332
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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