Custom Medical Specialties Recalls Radiology Drainage Packs with PVP Prep Solution
Custom Medical Specialties is recalling Abington Radiology Drainage Packs containing PVP Prep Solution because the solution lacked microbial testing and did not meet finished goods specifications.
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 source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4. As no specific deaths or injuries are reported in the text, the score is 4 (Severe) rather than 5 (Critical).
Plain-English summary
Custom Medical Specialties, Inc. is recalling 195 cases of CMS-8325-R2 and CMS-8325-R3 Abington Radiology Drainage Packs. These kits contain a 4 oz. bottle of PVP Prep Solution used for skin preparation. The recall was initiated after the firm identified a recall by the manufacturer of the Povidone Iodine Prep Solution on the FDA website.
The reason for the recall is that the PVP Prep Solution did not undergo microbial testing and did not meet proper finished goods specifications. The affected products were distributed nationwide, including in Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey, and Pennsylvania. Specific lot codes associated with the recall include 14267-0901, 14452-0902, 15205-0904, 16147-0907, 16690-0909, 17431-0911, 17708-0912, 17913-1001, 18240-1002, 18308-1002, 18345-1002, 18511-1002, 18739-1003, and 18829-1003.
Healthcare facilities and consumers should stop using these specific drainage packs and contact the recalling firm for instructions on return or disposal. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Affected units
- 195
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 (14)
- 14267-0901
- 14452-0902
- 15205-0904
- 16147-0907
- 16690-0909
- 17431-0911
- 17708-0912
- 17913-1001
- 18240-1002
- 18308-1002
- 18345-1002
- 18511-1002
- 18739-1003
- 18829-1003
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.
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