The Recall Desk
ModerateFDA (Devices)·Z-2130-2020·Announced 2020-06-03

Teleflex Recalls Sprotte Lumbar Puncture Needles Due to Sterility Concerns

Teleflex Medical is recalling 800 Sprotte lumbar puncture needles because a packaging issue prevents the manufacturer from guaranteeing 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: This is a voluntary precautionary recall due to a packaging issue that compromises sterility guarantees, without reported illnesses or injuries, fitting the Moderate severity criteria.

Plain-English summary

Teleflex Medical is recalling 800 units of Sprotte lumbar puncture needles (REF 33115131B w/ Intro 20 G x 3.5"). These devices are intended to gain entry into the spinal cavity for diagnostic procedures, myelography, or discography. The recall is being conducted by Teleflex Medical, which distributes products from Pajunk Medical.

The recall was initiated after Pajunk Medical identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this packaging defect, Pajunk cannot guarantee the sterility of the affected devices. The affected lot numbers are 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, and 74L1800502.

The affected devices were distributed nationwide. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the devices if they match the recalled lots. No specific instructions for consumers are provided in the source text, as these are professional medical devices.

The recalled product

Product
Sprotte Needle, REF 33115131B w/ Intro 20 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
Affected units
800

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)

  • Lot/Batch Numbers: 74A1900703
  • 74D1802540
  • 74E1800978
  • 74F1801413
  • 74G1800896
  • 74H1800162
  • 74K1801738
  • 74K1802909
  • 74L1800502

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.

See all 2 products in this recall →