Egyptian Drug Authority · Egypt
DEA-EG-2021-0012
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(12) For 2021
- Date issued
- 14 Mar 2021
- Recorded by us
- 2026-09-06 19:49:24 UTC
- Product
- Captivator Single – Use Snares
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Not stated by the issuing authority
- ATC code
- Not stated by the issuing authority
- Affected markets
- Egypt — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- ARABS REPUBLIC OF EGYPT جمصوريه مصر «بعريبيه EGYPTIAN DRUG AUTHORITY LL هيئنة الدواء المصرية WAC AN الإدارة المركزية للعمليات CA OF OPERATIONS a 4 : > لمركزب 2 4) إدارة التفتيش على المستلزمات الطبية ا قإدل MEDICAL DEVICE INSPECTION 2 7 0806 Po “oe « LR) 2021 dud )١)( منشور دورى رقم نههافسطة.................. del] السيد الدكتور / وكيل الوزاره للشمُون ” ادارة الصيدلة ” برجاء ضبط وتحريز ما يوجد بالسوق المصري بعد اتخاذ كافة الاجراءات المخزنية و نلك : للتشغيلة الواردة من المستلزم الطبي الآتي بياناته 24782695 171/2014/1 Captivator Single -Use Snares Boston Scientific Corporation المنتجة: as Costa Rica : بلد المنشا على سبب التحريز الآتي و الذي تم افادتنا به من الإدارة المركزية للرعاية الصيدلية: glia Boston Scientific Corporation is conducting a removal of specific lots of the Captivator Single-Use Polypectomy Snares , Captivator II Single- Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares , and Sensation Single-Use Polypectomy Snares. Boston Scientific has received complaints that the inner pouch for the specified lots of polypectomy snare devices impacted by this removal may have an incomplete seal which could result in a sterile barrier breach rendering the device non sterile .The most common health risk is a negligible prolongation in procedure in order to exchange for another device .Use of a polypectomy snare from a package with a sterile barrier breach may present a remote potential for a risk of infection ,representing the most severe health consequence. Boston Scientific is not aware of any patient consequences resulting from this issue. مع تسليم مندوب الشركة الأحراز بعد أخن التعهد اللازم بعدم فض الأختام إلا فى وجود مفتشى هيئة الدواء المصرية . مع موافاتنا بالكميات التى تم تحريزها وتاريخ ومكان الضبط والتحريز +» وتفضلوا بقبول وافر الاحترام»؛ w ئيس الة 1 رئيس م رز مدير ادارة =e J د. سالي عبد الرُسول التفتيش على المستلزمات الطبية lie رر لل . Av fv رئيس الإدارة المركزية للعمليات 8 1 ا شب الدواء المحسري * ee ١ دي Ee 00 من 1 ِ 681/0.07.8 203 . /لابلا/لا 1 فته ل 15301Original language: ar
- Notice text in English
- Not translated. Only the authority's own words above are held.
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 1
Where this record came from, and what is held to show it.
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- 73e0225cd16e4a08f058a1263d807388014edacd6d90e46b1e88bbc9c7f34d57SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-06 20:34:50 UTC
Cite this record
Drug Eye Africa (2021). DEA-EG-2021-0012: Captivator Single – Use Snares — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2021/dea-eg-2021-0012Version history
—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.