Egyptian Drug Authority · Egypt
DEA-EG-2021-0008
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
- Issuing authority
- Egyptian Drug Authority (EDA)
- Authority reference
- Periodic report no.(8) For 2021
- Date issued
- 18 Feb 2021
- Recorded by us
- 2026-09-06 19:49:24 UTC
- Product
- Capiox FX Advance oxygenator with integrated Arterial filter and Hard shell Reservoir X –Coating
- 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
- ARRAS REPUBLIC QF EGYPT 7 Le جمصوريه مصر EGYPTIAN DRUG AUTHORITY هيثة الدواء المصرية EES الإدارة المركزية للعمليات كح CA OF OPERATIONS 2 (4 } َ لمركزب : i | EDM إدارة التفتيش على المستلزمات الطبية ا MEDICAL DEVICE INSPECTION 0 /7 007 ٠و . LX) 2021 أحسنة (A) منشور دورى رقم نههاقطة.................. del] Guild السيد الدكتور / وكيل الوزاره ” ادارة الصيدلة ” برجاء ضبط وتحريز ما يوجد بالسوق المصري بعد اتخاذ كافة الاجراءات المخزنية و نلك : للتشغيلة الواردة من المستلزم الطبي الآتي بياناته YD16 589/2017/1 3CX Capiox FX25RWC | FX Advance oxygenator with integrated Arterial filter and Hard shell Reservoir X-Coating Terumo Crdiovascular Systems Corp.:asiiell الشركة United States of 121061108 بلد المنشا: : اسم طالب التسجيل:سبكترا جروب للمستلزمات و الأجهزة الطبية. بناء" على سبب التحريز الآتي و الذي تم افادتنا به من الإدارة المركزية للرعاية الصيدلية: The oxygenator configuration does not match the product code on the product labeling. Terumo CVS has determined that this tissue originated from an error within the assembly process where the east\west configuration did not match the unit identification .The functionally and performance of oxygenator is not comprised by the configuration discrepancy . The east vs. west configuration describes the placement of the water ports and the blood inlet port in relation to the blood outlet port of the oxygenator. The difference between the port placement on the oxygenator only impacts direction of the perfusion circuit which is a preference to perfusionist . We used the east and west oxygenator. The difference between it is the site of configuration and we informed the custom with it . This orientation difference has no impact on the functionality or safety of the product مع تسليم مندوب الشركة الأحراز بعد أخن التعهد اللازم بعدم فض الأختام إلا فى 9 392 مفتشى هيئة الدواء المصرية وتفضلوا بقبول وافر الاحترام»؛ we رئيس اله مدير ادارة at. 5 7 ا wh الا 5, د سال لدان رت التفتيش على المستلزمات الطبية ََ د.رباب بهنساوي - —— [J Md 0 دترت رئيس الإدارة المركزية للعمليات >> ْ الادارة المركزية للعمليات ِِ د. يس رجائي lal على — aid العحاسد 3 kdl : Eggi € www.edaegypt.gov.eg ly 1 1 من 1 فج & 15501 memeOriginal 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
- 7ebb2d476d6272afc350299afcc5422336eafa17e746998919eaa5926249cbb0SHA-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 20:34:43 UTC
Cite this record
Drug Eye Africa (2021). DEA-EG-2021-0008: Capiox FX Advance oxygenator with integrated Arterial filter and Hard shell Reservoir X –Coating — Recall, Egyptian Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/eg/2021/dea-eg-2021-0008Version 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.