The Recall Desk
HighFDA (Devices)·Z-2220-2019·Announced 2019-08-14

ROi Recalls Custom Surgical Packs Containing Stryker Pneumosure Tubesets

ROi Consolidated Service Center is recalling 261 custom surgical packs containing Stryker Pneumosure tubesets that may detach from the cassette, potentially causing gas leaks.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect in a medical device that could lead to gas leaks or hissing sounds, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Resource Optimization & Innovation (ROi) is recalling 261 custom surgical packs labeled as "LAP - FLOL LADY OF ANGELS" that contain specific Stryker Pneumosure tubesets. The recall was initiated after ROi received a notice from Stryker regarding a defect in the tubesets.

The affected Stryker part numbers are 0620 040 660 (Pneumosure High Flow II Tubeset), 0620 040 690 (Pneumosure Heated Tubeset with RTP), and 0620 040 680 (Pneumosure High Flow Tubeset with RTP). The defect involves the tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound during use.

The recalled packs were distributed to locations in Louisiana (LA) and Missouri (MO). Specific lot numbers and expiration dates are listed in the agency's recall record. Healthcare facilities and consumers should stop using these specific packs and contact ROi Consolidated Service Center for instructions on returning the product.

The recalled product

Product
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
Manufacturer
ROi Consolidated Service Center (CSC)
Category
Medical Device — Surgical Packs
Hazard
Affected units
261

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 (19)

  • Item Number (Lot Number
  • Expiration Date): 800096004 (044343D
  • 43590)
  • 800096004 (048023D
  • 43722)
  • 800096004 (049262D
  • 43757)
  • 800096004 (052020D
  • 43856)
  • 800096004 (054482D
  • 43948)
  • 800096004 (057619D
  • 44035)
  • 800096005 (059908E
  • 44080)
  • 800096005 (062938E
  • 44151)
  • 800096005 (65606E
  • 44232)

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by ROi Consolidated Service Center (CSC) 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 →

Related recalls

Same manufacturer · ROi Consolidated Service Center (CSC)

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Same hazard · gas leak

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