Hysteroscopic Sterilization Pack Recalled for Missing Microbial Testing
Custom Medical Specialties is recalling Hysteroscopic Sterilization Packs because the included Povidone Iodine Prep Solution lacked required microbial testing.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications."
Plain-English summary
Custom Medical Specialties, Inc. is recalling the CMS-8457 Hysteroscopic Sterilization Pack. The recall involves 3 cases of the product, which includes a 4 oz. bottle of PVP Prep (Povidone Iodine) used for skin preparation. The affected product codes are 15011-0904 and 16363-0908.
The recall was initiated after the firm observed an FDA website notice regarding a recall of the Povidone Iodine Prep Solution by its manufacturer. The reason for the recall is that the product did not undergo required microbial testing and failed to meet proper finished goods specifications.
The product was distributed nationwide in the United States, including in Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania. Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Affected units
- 3
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 (1)
- 15011-0904 and 16363-0908
Distribution
Part of a larger recall action
This product is one of 12 recalled by Custom Medical Specialties, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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