The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0736-2017·Announced 2016-12-21

C.R. Bard Recalls 70cc Piston Syringes Due to Package Defect

C.R. Bard is recalling 70cc Piston Syringes because a package slit defect may compromise product sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

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 hazard is a potential loss of sterility due to a packaging defect. No injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

C.R. Bard, Inc. is recalling the BARD 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap. The recall is due to a package defect where a slit in the packaging may affect the sterility of the product.

The affected product is a single-use plastic syringe with a 70cc capacity, designed for catheter irrigation, Cytoscope or Resectoscope irrigation, and Foley catheter balloon inflation. The specific product code is 0038470. The recall includes specific lot numbers: NGZC3890, NGZC4955, NGZD0763, NGZD2107, NGZD3104, NGZD3990, NGZD4739, NGZE1149, NGZE2054, NGZE3535, NGZF0244, NGZF1565, NGZF2670, NGZF4104, and NGZF5006.

The product was distributed worldwide, including the United States (nationwide), Australia, New Zealand, Canada, Mexico, France, and Italy. Users should check their inventory for the listed lot numbers and contact C.R. Bard for instructions on returning or disposing of the affected units.

The recalled product

Product
BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer…
Manufacturer
C.R. Bard, Inc.
Category
Medical Device — Syringes
Hazard

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 (15)

  • Product Code: 0038470
  • Lot Numbers: NGZC3890
  • NGZC4955
  • NGZD0763
  • NGZD2107
  • NGZD3104
  • NGZD3990
  • NGZD4739
  • NGZE1149
  • NGZE2054
  • NGZE3535
  • NGZF0244
  • NGZF1565
  • NGZF2670
  • NGZF4104 and NGZF5006.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by C.R. Bard, 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 4 products in this recall →

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