Iso-Gard Filter S Medical Gas Filter Recall Due to Splitting or Detachment
TELEFLEX LLC is recalling Iso-Gard Filter S microbial medical gas filters due to incidents where the device may split or detach during use. The FDA classified this as a Class I recall.
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: This is an FDA Class I medical device recall, which requires a minimum severity score of 4 per the rubric. Although no injuries or deaths are reported, the potential for device splitting or detachment in a medical gas filter presents significant risk of harm.
Plain-English summary
Iso-Gard Filter S with Expandi-Flex is a single-use microbial medical gas filter manufactured by TELEFLEX LLC. The FDA has classified this recall (Z-0073-2023) as Class I.
The recall was initiated due to incidents of device splitting or detaching during use. This hazard could affect the performance and safety of the filter during clinical use.
The recalled units (REF 19261 and 19272) were distributed nationwide in the United States. Seven units are included in this recall.
The recalled product
- Product
- Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
- Manufacturer
- TELEFLEX LLC
- Affected units
- 7
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 (9)
- a) 19261
- UDI: (01)04026704388486(17)260128(10)KMH21B0193
- (01)04026704388486(17)251028(10)KMH20L0234
- (01)04026704388486(17)260828(10)KMH21J0246
- (01)04026704388486(17)261028(10)KMH21L0294
- (01)04026704388486(17)261228(10)KMH22A0230
- b) 19272
- UDI: (01)04026704388509(17)260428(10)KMZ21E0613
- (01)04026704388509(17)260528(10)KMZ21F0939
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by TELEFLEX LLC 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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