The Recall Desk
SevereFDA (Devices)·Z-2355-2012·Announced 2012-09-26

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.

What this means for you

Illness, injury, or structural failure has been reported. 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.
Category
Medical Device — Radiology Drainage Pack
Hazard
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

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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

Same manufacturer · Custom Medical Specialties, Inc.

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Same hazard · microbial contamination

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