Wallace Oocyte Retrieval Sets 16G, 17G – Models MEONS 1633S, MEONS 1733S

• • Terminated Z-0593-2009 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008

  Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.

Full name

Wallace Oocyte Retrieval Sets 16g, Wallace Oocyte Retrieval Set 17g, Models Meons 1633S, Meons 1733S

510(k) Number

K012068 ↗

FDA Product Code

MQE

FDA applicant

Sims Portex , Ltd.

Device Class

Class II

Regulation

21 CFR Part 884.6100

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Csecure Combined Spinal/Epidural Anesthesia System with Lock

  Class II

  FDA 510(k) K993619 Active Cleared 28 Apr 2000

• Wallace Oocyte Retrieval Set-16g, Model MEONS1633; Wallace Oocyte Retrieval Set-17g, Model MEONS1733

  Class II

  FDA 510(k) K000628 Active Cleared 13 Mar 2000

• Sims Portex Epidural Catheter, 20g Model# 4910-16/17; 21g Model# 4910-18

  Class II

  FDA 510(k) K992471 Active Cleared 22 Oct 1999

• Spinal Anesthesia Needles and Introducer Needles

  Class II

  FDA 510(k) K983858 Active Cleared 29 Jan 1999

• Sims Portex Anesthesia Catheter

  Class II

  FDA 510(k) K994275 Active Cleared 22 Feb 2000

• Cpap System, Model 102001

  Class II

  FDA 510(k) K001318 Active Cleared 20 Jul 2000

See all devices from Sims Portex, Inc. →

• What are the Wallace Oocyte Retrieval Sets designed for?

  The Wallace Oocyte Retrieval Sets are specifically designed for transvaginal oocyte retrieval during assisted reproductive procedures. Their tri-faceted or triple-ground needle tips enhance precision under ultrasound guidance, ensuring accurate needle placement to retrieve oocytes efficiently. This design supports both continuous and intermittent flushing techniques to maximize collection success.

• How are the 16G and 17G gauges differentiated, and why does this matter?

  The 16G and 17G gauges are distinguished by color-coded tubing sleeves—blue for 16G and red for 17G. This color-coding helps clinicians quickly identify the correct needle size for their specific clinical needs. The gauge choice may influence procedural comfort, precision, and retrieval efficiency, allowing clinicians to select based on patient anatomy or retrieval requirements.

• Are the Wallace Oocyte Retrieval Sets reusable or single-use?

  The Wallace Oocyte Retrieval Sets are intended for single-use only. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in sterile clinical settings like fertility clinics or operating rooms. Single-use devices also eliminate the need for reprocessing, streamlining workflow and maintaining compliance with sterile procedure protocols.

• What storage instructions should be followed for these devices?

  While specific storage instructions aren’t detailed in the regulatory data, standard sterile medical device handling applies. These sets should be stored in a clean, dry environment protected from moisture, dust, and extreme temperatures. Proper packaging should remain intact until immediate use to preserve sterility. Always follow manufacturer guidelines for unopened and opened device storage to ensure optimal performance and safety.

• Are these needles compatible with MRI procedures?

  The Wallace Oocyte Retrieval Sets are not labeled for MRI compatibility. Clinicians should verify compatibility with their specific MRI equipment and protocols before use, as non-compatible materials or devices can pose risks during imaging. If MRI guidance is required, alternative retrieval methods or MRI-safe devices should be considered.