Medline Pacemaker Implant Pack Recalled for Subpotent Iodine Concentration
Medline Industries is recalling Pacemaker Implant Packs because the Povidone-Iodine prep pads contain less iodine than labeled.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or property damage (or structural defects) are rated Severe (4). While no specific injuries are reported in the text, the subpotent nature of a sterile prep product for implant surgery carries significant risk.
Plain-English summary
Medline Industries Inc. is recalling 66 cases of Medline Pacemaker Implant Packs, Sterile, Single Use Only. The product was packaged in Mexico by Medline Industries, Inc., in Mundelein, IL. The recall is due to a subpotent drug issue where the titratable iodine contained in the Povidone-Iodine prep pads is below the label claim of 0.85%.
The affected products are identified by Pack Number DYNJ32856C and Lots 17SB6210, 17FB5359, and 17SB6208. The distribution pattern includes the United States, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, and Turkey.
The FDA has classified this recall as Class II. Consumers and healthcare providers should check their inventory for the specific lot numbers and pack number listed above. If the product is found, it should be returned to Medline Industries Inc. or the original supplier for credit or replacement.
The recalled product
- Product
- Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
- Manufacturer
- Medline Industries Inc
- Category
- Drug — Medical Supplies
- Affected units
- 66
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 (4)
- Pack Number: DYNJ32856C
- Lots 17SB6210
- 17FB5359
- 17SB6208
Distribution
Part of a larger recall action
This product is one of 68 recalled by Medline Industries Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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