Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns
Teleflex Medical is recalling 4,227 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing their sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a voluntary precautionary recall based on a packaging issue that compromises sterility guarantees, without reporting any specific illnesses or injuries.
Plain-English summary
Teleflex Medical is recalling 4,227 Sprotte lumbar puncture needles, reference number 32115130C, with 22 G x 3.5" introducers. These devices are intended to gain entry into the spinal cavity for diagnostic or therapeutic procedures. The recall is due to a packaging problem identified by the manufacturer, Pajunk Medical, which affects the ability to guarantee the sterility of the affected batches.
The affected devices were distributed nationwide. The specific lot numbers involved are 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, and 74L1802219. Teleflex Medical serves as the distributor for these Pajunk Medical products.
Healthcare providers and facilities should check their inventory for these specific lot numbers. If the devices are found, they should be removed from use and returned to Teleflex Medical or the supplier for further instructions.
The recalled product
- Product
- Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic l
- Manufacturer
- TELEFLEX MEDICAL INC
- Affected units
- 4,227
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 (10)
- Lot/Batch Numbers: 74A1900698
- 74C1902955
- 74C1900349
- 74C1900137
- 74E1802338
- 74G1802129
- 74H1802488
- 74K1800901
- 74K1801734
- 74L1802219
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by TELEFLEX MEDICAL 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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